Datex Division Instrumentarium Corp.
Walker, MI, US
Datex Division Instrumentarium Corp. appears in FDA device records in Walker, MI. FDA records list 55 510(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
- 55
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
Showing 50 of 55FDA records hold 55 510(k) clearances for Datex Division Instrumentarium Corp. between 1982 and 1997. The busiest year on record is 1988, with 7. The most recent is 1997, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1982 | 1 |
| 1983 | 1 |
| 1984 | 3 |
| 1986 | 4 |
| 1987 | 5 |
| 1988 | 7 |
| 1989 | 5 |
| 1990 | 5 |
| 1991 | 6 |
| 1992 | 3 |
| 1993 | 4 |
| 1994 | 7 |
| 1995 | 2 |
| 1996 | 1 |
| 1997 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K953175 | AS/3 ESTPR MODULE | MLD | Substantially Equivalent | |
| K961247 | AS/3 LIGHT MONITOR | DPS | Substantially Equivalent | |
| K943458 | AS/3 AIRWAY MODULE | CBS | Substantially Equivalent | |
| K945234 | AS/3 MEMORY MODULE, M0MEM | BSZ | Substantially Equivalent | |
| K933156 | DATEX AS/3 PATIENT MONITOR | DPS | Substantially Equivalent | |
| K933285 | DATEX AS/3 TM ANAESTHESIA MONITOR | BSZ | Substantially Equivalent | |
| K943456 | AS/3 NELLCOR COMPATIBLE SATURATION MOODULE, M-NSAT | DQA | Substantially Equivalent | |
| K923172 | ANAESTHESIA RECORD KEEPER | BSZ | Substantially Equivalent | |
| K935477 | AS/3(TM) ANESTHESIA MONITOR SYST INTERFACE BOARD | CCK | Substantially Equivalent | |
| K943457 | AS/3 PRESSURE TEMPERATURE MODULE, M-PT | DSK | Substantially Equivalent | |
| K933284 | AS/3 TM NETWORK | CCK | Substantially Equivalent | |
| K932098 | CAPNOMAC ULTIMA ANESTHESIA MONITOR | BZK | Substantially Equivalent | |
| K931422 | DELTATRAC(TM) II METABOLIC MONITOR | BZL | Substantially Equivalent | |
| K923276 | CAPNOMAC ULTIMA ANESTHESIA MONITOR | CBQ | Substantially Equivalent | |
| K922876 | AS/3 COP MODULE | CBQ | Substantially Equivalent | |
| K911645 | NGM NIBP MODULE | DXN | Substantially Equivalent | |
| K911644 | NGM FRAME | CBQ | Substantially Equivalent | |
| K911646 | NGM ESTP MODULE | MHX | Substantially Equivalent | |
| K911647 | NGM GAS MODULE | CBQ | Substantially Equivalent | |
| K903237 | CARDIOCAP CMX-104 MONITOR | DXN | Substantially Equivalent | |
| K905754 | CAPNOMAC ULTIMA ANESTHESIA MONITOR | CBS | Substantially Equivalent | |
| K905140 | SATLITE PLUS PULSE OXIMETER | DQA | Substantially Equivalent | |
| K910620 | CARDIOCAP DR-124 RECORDER | DRG | Substantially Equivalent | |
| K903104 | CAPNOMAC ULTIMA (TM) ANESTHESIA MONITOR | CBQ | Substantially Equivalent | |
| K896652 | CAPNOMAC ULTIMA(TM) ANESTHESIA MONITOR | CCK | Substantially Equivalent | |
| K902493 | CARDIOCAP II CG-2GS, 2G, 1GS, 1G, 2CG, CS MONITOR | DRI | Substantially Equivalent | |
| K902492 | CARDIOCAP II MONITORS: CH, CH-2, CH-S, CH-2S | DRI | Substantially Equivalent | |
| K896190 | CARDIOCAP(TM) CMX-104 MONITOR | DPS | Substantially Equivalent | |
| K897080 | CARDIOCAP(TM) CT-104 MONITOR | DRT | Substantially Equivalent | |
| K895780 | OSCAROXY(TM) GAS MONITOR AND PULSE OXIMETER | CCK | Substantially Equivalent | |
| K891076 | CAPNOMAC II(TM) ANESTHESIA MULTIGAS MONITOR | CCK | Substantially Equivalent | |
| K885058 | CARDIOCAP(TM) DR-104 REPORTER | DSF | Substantially Equivalent | |
| K884991 | CARDIOCAP CCK-104 KEYBOARD & CCP-104 GRAPHICS PRIN | BSZ | Substantially Equivalent | |
| K890753 | SATLITE TRANS PORTABLE PULSE OXIMETER | DQA | Substantially Equivalent | |
| K884955 | CARDIOCAP(TM) CM-104 MONITOR | DXN | Substantially Equivalent | |
| K884956 | CARDIOCAP(TM) CTO-104 MONITOR | DPS | Substantially Equivalent | |
| K883877 | BM-103 BATTERY MODULE | DQA | Substantially Equivalent | |
| K882885 | DATEX AIRWAY MONITOR | CCK | Substantially Equivalent | |
| K882748 | NORMOCAP 200 CAPNOMETER | CCK | Substantially Equivalent | |
| K882093 | CARDIOCAP(TM) CMO-104 MONITOR | DSK | Substantially Equivalent | |
| K881883 | SATLITE+/PB251+ PULSE OXIMETER | DQA | Substantially Equivalent | |
| K873859 | CARDIOCAP(TM) PULSE OXIMETRY MODULE COS-104 | DQA | Substantially Equivalent | |
| K872760 | OSCAR(TM) PB255 OXIMETER CAPNOMETER | CCK | Substantially Equivalent | |
| K871826 | PB VIDEO DISPLAY TO PB251 PULSE OXIMETER UPGRADE | DQA | Substantially Equivalent | |
| K870621 | SATLITE/PB251 PULSE OXIMETER | DQA | Substantially Equivalent | |
| K864603 | DELTATRAC(TM) METABOLIC MONITOR | BZL | Substantially Equivalent | |
| K862455 | MODIFIED CARDIOCAP MONITOR | DSK | Substantially Equivalent | |
| K863248 | PB GRAPHICS PRINTER AND PB VIDEO DISPLAY | CBQ | Substantially Equivalent | |
| K861474 | PB253 TO PB254 IR - SPECTROMETER UPGRADE KIT | CBQ | Substantially Equivalent | |
| K861213 | PB 254 IR - SPECTROMETER | CCK | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-Phase
- CBQAnalyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)
- CBSAnalyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)
- DSKComputer, Blood-Pressure
- BZLComputer, Oxygen-Uptake
- DPSElectrocardiograph
- IKNElectromyograph, Diagnostic
- BSZGas-Machine, Anesthesia
- DRTMonitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
- DRIMonitor, Line Isolation
- MHXMonitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
- MLDMonitor, St Segment With Alarm
- OLTNon-Normalizing Quantitative Electroencephalograph Software
- DQAOximeter
- DSFRecorder, Paper Chart
- BZKSpirometer, Monitoring (W/Wo Alarm)
- KOIStimulator, Nerve, Peripheral, Electric
- 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