Hewlett-Packard Co.
Mchenry, IL, US
Hewlett-Packard Co. appears in FDA device records in Mchenry, IL. FDA records list 246 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 246
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
Showing 50 of 246FDA records hold 246 510(k) clearances for Hewlett-Packard Co. between 1976 and 2000. The busiest year on record is 1977, with 17. The most recent is 2000, with 4.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1976 | 14 |
| 1977 | 17 |
| 1978 | 9 |
| 1979 | 10 |
| 1980 | 6 |
| 1981 | 5 |
| 1982 | 8 |
| 1983 | 11 |
| 1984 | 11 |
| 1985 | 11 |
| 1986 | 8 |
| 1987 | 3 |
| 1988 | 10 |
| 1989 | 8 |
| 1990 | 11 |
| 1991 | 13 |
| 1992 | 10 |
| 1993 | 8 |
| 1994 | 8 |
| 1995 | 10 |
| 1996 | 12 |
| 1997 | 9 |
| 1998 | 14 |
| 1999 | 16 |
| 2000 | 4 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K992543 | HEARTSTREAM XLT DEFIBRILLATOR/MONITOR, AC CHARGER, DC CHARGER, DATA CARD, SINGLE BAY ADAPTER, DEFIBRILLATOR PADS CABLE | MKJ | Substantially Equivalent | |
| K993383 | HP VIRIDIA MULTI-MEASUREMENT SERVER/COMPACT PORTABLE PATIENT MONITOR MODELS M3000A, M3046A, M3015A, REL.B | DSI | Substantially Equivalent | |
| K992273 | HP VIRIDIA MULTI-MEASUREMENT SERVER/COMPACT PORTABLE PATIENT MONITOR M3000A/M3046A/M3016A,REL B | MHX | Substantially Equivalent | |
| K993587 | HP M2376A DEVICE LINK SYSTEM | MQS | Substantially Equivalent | |
| K993169 | MODIFICATION OF: PHYSIOLOGICAL SIGNAL TRANSMITTER AND RECEIVER, MODEL 3810A | DRG | Substantially Equivalent | |
| K992595 | HP VIRIDIA COMPONENT MONITORING SYSTEM, MODEL REV. K WITH EASI-ST SEGMENT MEASUREMENT, HP VIRIDIA CMS 24/26, REV K WITH | MHX | Substantially Equivalent | |
| K992977 | HEWLETT PACKARD MULTIFUNCTION PEDIATRIC DEFIB FUNCTION, MODEL M3503A & M3504A | MKJ | Substantially Equivalent | |
| K993516 | HP M2600A VIRIDIA TELEMETRY SYSTEM | DSI | Substantially Equivalent | |
| K992674 | HP VIRIDIA CMS PATIENT MONITOR WITH EEG PARAMETER, MODEL M1027A | MHX | Substantially Equivalent | |
| K993171 | HP VIRIDIA INFORMATION SYSTEM, MODELS M3150A/ M3151A/ M3153A/ M3154A | DSI | Substantially Equivalent | |
| K992636 | HP CAREVUE 9000 CLINICAL INFORMATION SYSTEM, MODEL M2331A | DXJ | Substantially Equivalent | |
| K991871 | HEWLETT PACKARD MULTI FUNCTION ADULT DEFIB ELECTRODE, MODEL M3501A & M3502A | MKJ | Substantially Equivalent | |
| K990476 | HP VIRIDIA COMPONENT MONITORING SYSTEM, HP VIRIDIA CMS 24/26, MODEL REV. K WITH EASI-ECG OPTION | MHX | Substantially Equivalent | |
| K991773 | HP VIRIDIA COMPONENT MONITORING SYSTEM, HP VIRIDIA CMS 24/26, HP VIRIDIA MULTI-MEASUREMENT SERVER AND COMPACT PORTABLE P | DSI | Substantially Equivalent | |
| K984194 | HP M2376A DEVICE LINK SYSTEM | MQS | Substantially Equivalent | |
| K990972 | HP VIRIDIA COMPONENT MONITORING SYSTEM, HP VIRIDIA CMS 24/26, HP VIRIDIA MULTI-MEASUREMENT SERVER AND COMPACT PORTABLE T | DSI | Substantially Equivalent | |
| K990400 | LINEAR ARRAY TRANSDUCER,MODEL HP 21376, M2410A ULTRASOUND IMAGING SYSTEM | ITX | Substantially Equivalent | |
| K990339 | SONOS 5500 IMAGING SYSTEM M2424A VERSION B.O | IYN | Substantially Equivalent | |
| K990125 | HP VIRIDIA COMPONENT MONITORING SYSTEM, MODEL REV. K | DSI | Substantially Equivalent | |
| K981376 | HEWLETT-PACKARD M1205A VIRIDIA 24 CT | DSI | Substantially Equivalent | |
| K984286 | HEARTSTREAM ELECTRODE ADAPTER | MKJ | Substantially Equivalent | |
| K980429 | HP M2600A VIRIDIA TELEMETRY SYSTEM (FORMERLY KNOWN AS THE HP 2600A OMNI-CARE TELEMETRY SYSTEM) | DSI | Substantially Equivalent | |
| K982025 | HEWLETT-PACKARD M2475B WITH 12-LEAD OPTION (#C90) CODEMASTER 100 CONITOR/DEFIBRILLATOR | MKJ | Substantially Equivalent - Subject to Tracking Reg. | |
| K982619 | HP ANESTHESIA GAS MONITOR (WATERTRAP), MODEL A02 | CCL | Substantially Equivalent | |
| K981576 | MULTI-PARAMETER MODULE, MODEL M3000A & DISPLAY UNIT, MODEL M3046A | MHX | Substantially Equivalent | |
| K974457 | SCOUT 3.2/45 MHZ CORONARY IMAGING CATHETER, SCOUT 3.2/45 MHZ CORONARY IMAGING CATHETER, SCOUT IMAGING CATHETER PATIENT T | IYO | Substantially Equivalent | |
| K981265 | PAGEWRITER 200I INTERPRETIVE CARDIOGRAPH MODEL M1770A WITH ACUTE CARDIAC ISCHEMIA TIME INSENSITIVE PREDICTIVE INSTRUMENA | LOS | Substantially Equivalent | |
| K974087 | MODEL M1792A THROMBOLYTIC PREDICTIVE INSTRUMENT | LOS | Substantially Equivalent | |
| K980687 | SONOS 5500 ULTRASOUND IMAGING SYSTEM | IYO | Substantially Equivalent | |
| K971910 | MULTI-PARAMETER MODULE (M3000A)/DISPLAY UNIT (M3046A) | DSI | Substantially Equivalent | |
| K974746 | M1765A ECG MANAGER | DPS | Substantially Equivalent | |
| K974420 | M1730B TRACEMASTER ECG SYSTEM, M1766B LOCAL EDIT STATION, M1798B REMOTE EDIT STATION | DSH | Substantially Equivalent | |
| K974567 | HEWLETT-PACKARD M2605A VIRIDIA WAVE VIEWER | MSX | Substantially Equivalent | |
| K971116 | SONOS 5500 IMAGING SYSTEM | ITX | Substantially Equivalent | |
| K973437 | HEWLETT-PACKARD MODELS M1001B ECG M1002B ECG/RESPIRATION PLUG-IN MODULES | DPS | Substantially Equivalent | |
| K970456 | HEWLETT APCKARD SERIES 50 OB TRACEVUE OBSTETRICAL SURVEILLANCE AND ARCHIVING SYSTEM | HGM | Substantially Equivalent | |
| K965160 | HP ORVUE INTRA-OP (M2510A) | BSZ | Substantially Equivalent | |
| K972348 | HP ENDOVAGINAL/ENDORECTAL PROBE, HP IMAGE POINT ULTRASOUND SYSTEM | ITX | Substantially Equivalent | |
| K964832 | HEWLETT-PACKARD CENTRALVUE SOFTWARE | DSI | Substantially Equivalent | |
| K964309 | SONOS 2000, SONOS 2500 (M2406 A) | IYN | Substantially Equivalent | |
| K963706 | PHILIPS SONO DIAGNOST 800 | IYO | Substantially Equivalent | |
| K970034 | SD 800 SONODIAGNOST ULTRASOUND IMAGING SYSTEM | ITX | Substantially Equivalent | |
| K964122 | HP STAR ST AND ARRHHYTHMIA SOFTWARE | DSI | Substantially Equivalent | |
| K961165 | HP M2600A OMNICARE TELEMETRY SYSTEM MODEL M2600A | DSI | Substantially Equivalent | |
| K961401 | HP CATHSTATION - MODEL M1264B | DPS | Substantially Equivalent | |
| K954028 | HP SONOS ULTRASOUND IMAGING SYSTEM | IYN | Substantially Equivalent | |
| K961009 | STRESSWRITER EXERCISE TESTING SYSTEM | DQK | Substantially Equivalent | |
| K960934 | HP M1205A OMNICARE COMPONENT MONITOR SYSTEM MODEL 24 | MLD | Substantially Equivalent | |
| K954980 | PAGEWRITER 200, 200I CARDIOGRAPH & INTERPRETIVE CARDIO | LOS | Substantially Equivalent | |
| K954957 | CODEMASTER XL + XL W/SHOCK ADVISORY OPTION | MKJ | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- DTLAdaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
- DRRAmplifier And Signal Conditioner, Biopotential
- CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-Phase
- CCJAnalyzer, Gas, Carbon-Monoxide, Gaseous-Phase
- CBSAnalyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)
- CCLAnalyzer, Gas, Oxygen, Gaseous-Phase
- KIEApparatus, High Pressure Liquid Chromatography
- MKJAutomated External Defibrillators (Non-Wearable)
- DXQBlood Pressure Cuff
- JQPCalculator/Data Processing Module, For Clinical Use
- KZQChromatography(Gas), Clinical Use
- DIIColumns, Glc
- DSKComputer, Blood-Pressure
- DXGComputer, Diagnostic, Pre-Programmed, Single-Function
- DQKComputer, Diagnostic, Programmable
- LDDDc-Defibrillator, Low-Energy, (Including Paddles)
- DSIDetector And Alarm, Arrhythmia
- FFGDevice, Urine Flow Rate Measuring, Non-Electrical, Disposable
- DXJDisplay, Cathode-Ray Tube, Medical
- DXKEchocardiograph
- GXWEchoencephalograph
- DPSElectrocardiograph
- HGPElectrode, Circular (Spiral), Scalp And Applicator
- DRXElectrode, Electrocardiograph
- DPWFlowmeter, Blood, Cardiovascular
- BSZGas-Machine, Anesthesia
- LFLInstrument, Ultrasonic Surgical
- LDMInstrumentation, High Pressure Liquid Chromatography
- LKDMonitor, Carbon-Dioxide, Cutaneous
- DRTMonitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
- KXNMonitor, Cardiac, Fetal
- KLKMonitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia
- MHXMonitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
- KXOMonitor, Pressure, Intrauterine
- MLDMonitor, St Segment With Alarm
- DQAOximeter
- DROPacemaker, Cardiac, External Transcutaneous (Non-Invasive)
- DQCPhonocardiograph
- DPTProbe, Blood-Flow, Extravascular
- DSHRecorder, Magnetic Tape, Medical
- DSFRecorder, Paper Chart
- MQSSystem, Hemodialysis, Access Recirculation Monitoring
- LLZSystem, Image Processing, Radiological
- IYNSystem, Imaging, Pulsed Doppler, Ultrasonic
- IYOSystem, Imaging, Pulsed Echo, Ultrasonic
- DXNSystem, Measurement, Blood-Pressure, Non-Invasive
- HGMSystem, Monitoring, Perinatal
- MSXSystem, Network And Communication, Physiological Monitors
- IZLSystem, X-Ray, Mobile
- DRSTransducer, Blood-Pressure, Extravascular
- JOPTransducer, Ultrasonic
- ITXTransducer, Ultrasonic, Diagnostic
- HGLTransducer, Ultrasonic, Obstetric
- DXHTransmitters And Receivers, Electrocardiograph, Telephone
- DRGTransmitters And Receivers, Physiological Signal, Radiofrequency
- KNTTubes, Gastrointestinal (And Accessories)
- CBKVentilator, Continuous, Facility Use
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain