Spacelabs, Inc.
Mchenry, IL, US
Spacelabs, Inc. appears in FDA device records in Mchenry, IL. FDA records list 46 510(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
- 46
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 46 510(k) clearances for Spacelabs, Inc. between 1976 and 1996. The busiest year on record is 1986, with 8. The most recent is 1996, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1976 | 4 |
| 1978 | 1 |
| 1979 | 2 |
| 1981 | 1 |
| 1983 | 2 |
| 1984 | 7 |
| 1985 | 3 |
| 1986 | 8 |
| 1987 | 1 |
| 1989 | 2 |
| 1990 | 6 |
| 1991 | 3 |
| 1992 | 1 |
| 1993 | 1 |
| 1994 | 1 |
| 1995 | 2 |
| 1996 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K954962 | SPACELABS MEDICAL MULTIGAS ANALYZER | CBR | Substantially Equivalent | |
| K951605 | SPACELABS MEDICAL CASEMASTER INFORMATION MANAGEMENT SYSTEM | DSH | Substantially Equivalent | |
| K950779 | HEART RATE VARIABILITY SOFTWARE OPTION | DPS | Substantially Equivalent | |
| K941165 | COMET CAPNOGRAPH MODULE | CCK | Substantially Equivalent | |
| K923788 | SPACE LABS MODEL 90560 | LOS | Substantially Equivalent | |
| K912742 | ESOPHAGEAL STETHOSCOPE TEMPERATURE PROBE | FLL | Substantially Equivalent | |
| K913038 | SPACELAB MODEL 90845 PCMS MULTIDISCLOSURE STATION | DSH | Substantially Equivalent | |
| K905065 | DEFIBRILLATOR LEAD ADAPTER | LDD | Substantially Equivalent | |
| K910029 | PATIENT CARE MANAGEMENT SYSTEM MODIFICATION | DXK | Substantially Equivalent | |
| K896903 | FIRST MEDIC MODEL 510 | LDD | Substantially Equivalent | |
| K904318 | LOCAL REPORT GENERATOR | DXN | Substantially Equivalent | |
| K903702 | MODEL 90421 FLEXPORT INTERFACE | DQA | Substantially Equivalent | |
| K901209 | MODEL 90489 PULSE OXIMETER MODULE | DQA | Substantially Equivalent | |
| K896942 | SPACELABS MODEL 90480 EEG MODULE | GWQ | Substantially Equivalent | |
| K896427 | SPACELABS' MODEL 90514, MULTIGAS ANALYZER | CCL | Substantially Equivalent | |
| K894093 | SPACELABS MODEL 90900 | LOS | Substantially Equivalent | |
| K893867 | CARDIAC OUTPUR/SATURATED VENOUS OXYGEN MODULE | DQA | Substantially Equivalent | |
| K864279 | SPACELABS MODEL 90419 PULSE OXIMETER MODULE | DQA | Substantially Equivalent | |
| K864506 | SPACELABS - ARRHYTHMIA NET (TM) LEVEL 1 | DSI | Substantially Equivalent | |
| K864505 | SPACELABS ARRHYTHMIA NET (TM) LEVEL 2 | DSI | Substantially Equivalent | |
| K862951 | SPACELABS SERIES 90700 PATIENT MONITORS | DPS | Substantially Equivalent | |
| K855127 | AMBULATORY BLOOD PRESSURE MONITOR SPACELABS #90202 | DXN | Substantially Equivalent | |
| K860689 | SPACELABS P.C. CARDIAC OUTPUT/PRESSURE MODULE | DSK | Substantially Equivalent | |
| K860980 | PC ARRHYTHMIA DETECTION/ANALYSIS - ARRHYTHMIA III | DSI | Substantially Equivalent | |
| K860834 | SPACELABS MEDICAL WORKSTATION | DSI | Substantially Equivalent | |
| K860352 | SPACELABS AIRWAY ADAPTER SET SERIES, NO. 369014 | BZA | Substantially Equivalent | |
| K850627 | SPACELABS-GENERAL SYSTEM LINK | DQK | Substantially Equivalent | |
| K844940 | SPACELABS MODEL 90201 HOLTER RECORDER | DSH | Substantially Equivalent | |
| K844888 | SPACELABS SERIES 600 PATIENT MONITORS | DRT | Substantially Equivalent | |
| K842616 | SPACELABS ALPHA PC PATIENT COMPUTER | DSI | Substantially Equivalent | |
| K842640 | SPACELABS ICR ARRHYTHMIA MASTER I HOLTER | DSI | Substantially Equivalent | |
| K842978 | 540 CAPNOGRAPH | CCK | Substantially Equivalent | |
| K834597 | ALPHA MASS STORAGE CARDULE 1895 | DSI | Substantially Equivalent | |
| K834460 | MODEL 1888 ALPHA COS/RESPIRATION CAR | LLK | Substantially Equivalent | |
| K832764 | ALPHA NON-INVASIVE BP CARDULE | DXN | Substantially Equivalent | |
| K832644 | ALPHA CARDIAC OUTPUT CARDULE #1899 | DXG | Substantially Equivalent | |
| K832693 | ARRHYTHMIA III CARDULE #1919 | DSI | Substantially Equivalent | |
| K830306 | HEARTRATE PLUS ECG CARDULE #1918 | DSI | Substantially Equivalent | |
| K811540 | SPACELABS' SYSTEM AUTORECORDER | DSF | Substantially Equivalent | |
| K791776 | ARRHYTHMIA II EDITOR | DQK | Substantially Equivalent | |
| K790837 | ARRHYTHMIA II CARDULE | DSI | Substantially Equivalent | |
| K781836 | TELEMETRY SYSTEM, BIOTEL 300 | DRG | Substantially Equivalent | |
| K761244 | SERIES 700 PATIENT MONITORS | FLL | Substantially Equivalent | |
| K760884 | MICRO-COMPUTER ARRHYTHONIA SYSTEM | DSI | Substantially Equivalent | |
| K760612 | SPACELABS SERIES 1000 | DPS | Substantially Equivalent | |
| K760120 | PULSE CARDULE (MODEL 1859/1860 ECG) | DRT | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-Phase
- CBRAnalyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)
- CCLAnalyzer, Gas, Oxygen, Gaseous-Phase
- DSKComputer, Blood-Pressure
- DXGComputer, Diagnostic, Pre-Programmed, Single-Function
- DQKComputer, Diagnostic, Programmable
- BZAConnector, Airway (Extension)
- FLLContinuous Measurement Thermometer
- LDDDc-Defibrillator, Low-Energy, (Including Paddles)
- DSIDetector And Alarm, Arrhythmia
- DXKEchocardiograph
- DPSElectrocardiograph
- GWQFull-Montage Standard Electroencephalograph
- LLKLegging, Compression, Non-Inflatable
- DRTMonitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
- DQAOximeter
- DSHRecorder, Magnetic Tape, Medical
- DSFRecorder, Paper Chart
- DXNSystem, Measurement, Blood-Pressure, Non-Invasive
- DRGTransmitters And Receivers, Physiological Signal, Radiofrequency
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