Company ยท FI
Datex Division Instrumentarium Corp.
FDA 510(k) clearances and medical device recalls filed under this name, 1982 to 1997. Name variants (Inc, Corp, punctuation) are merged.
55510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | 9 |
| DQA | Oximeter | 8 |
| CBQ | Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) | 7 |
| BSZ | Gas-Machine, Anesthesia | 4 |
| DPS | Electrocardiograph | 4 |
| CBS | Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) | 3 |
| DSK | Computer, Blood-Pressure | 3 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 3 |
| BZL | Computer, Oxygen-Uptake | 2 |
| DRI | Monitor, Line Isolation | 2 |
| BZK | Spirometer, Monitoring (W/Wo Alarm) | 1 |
| DRG | Transmitters And Receivers, Physiological Signal, Radiofrequency | 1 |
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | 1 |
| DSF | Recorder, Paper Chart | 1 |
| IKN | Electromyograph, Diagnostic | 1 |
| KOI | Stimulator, Nerve, Peripheral, Electric | 1 |
| MHX | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | 1 |
| MLD | Monitor, St Segment With Alarm | 1 |
| OLT | Non-Normalizing Quantitative Electroencephalograph Software | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 6, 1997 | K953175 | AS/3 ESTPR MODULE Datex Division Instrumentarium Corp. | MLD |
| Oct 23, 1996 | K961247 | AS/3 LIGHT MONITOR Datex Division Instrumentarium Corp. | DPS |
| Feb 14, 1995 | K943458 | AS/3 AIRWAY MODULE Datex Division Instrumentarium Corp., FI | CBS |
| Jan 27, 1995 | K945234 | AS/3 MEMORY MODULE, M0MEM Datex Division Instrumentarium Corp., FI | BSZ |
| Dec 30, 1994 | K933156 | DATEX AS/3 PATIENT MONITOR Datex Division Instrumentarium Corp., FI | DPS |
| Nov 14, 1994 | K933285 | DATEX AS/3 TM ANAESTHESIA MONITOR Datex Division Instrumentarium Corp., FI | BSZ |
| Oct 17, 1994 | K943456 | AS/3 NELLCOR COMPATIBLE SATURATION MOODULE, M-NSAT Datex Division Instrumentarium Corp., FI | DQA |
| Aug 9, 1994 | K923172 | ANAESTHESIA RECORD KEEPER Datex Division Instrumentarium Corp., FI | BSZ |
| Aug 1, 1994 | K935477 | AS/3(TM) ANESTHESIA MONITOR SYST INTERFACE BOARD Datex Division Instrumentarium Corp., FI | CCK |
| Jul 27, 1994 | K943457 | AS/3 PRESSURE TEMPERATURE MODULE, M-PT Datex Division Instrumentarium Corp., FI | DSK |
| Jul 11, 1994 | K933284 | AS/3 TM NETWORK Datex Division Instrumentarium Corp., FI | CCK |
| Nov 29, 1993 | K932098 | CAPNOMAC ULTIMA ANESTHESIA MONITOR Datex Division Instrumentarium Corp., FI | BZK |
| Nov 24, 1993 | K931422 | DELTATRAC(TM) II METABOLIC MONITOR Datex Division Instrumentarium Corp., FI | BZL |
| Jul 21, 1993 | K923276 | CAPNOMAC ULTIMA ANESTHESIA MONITOR Datex Division Instrumentarium Corp., FI | CBQ |
| Jul 21, 1993 | K922876 | AS/3 COP MODULE Datex Division Instrumentarium Corp., FI | CBQ |
| Mar 4, 1992 | K911645 | NGM NIBP MODULE Datex Division Instrumentarium Corp. | DXN |
| Mar 4, 1992 | K911644 | NGM FRAME Datex Division Instrumentarium Corp. | CBQ |
| Feb 21, 1992 | K911646 | NGM ESTP MODULE Datex Division Instrumentarium Corp. | MHX |
| Sep 19, 1991 | K911647 | NGM GAS MODULE Datex Division Instrumentarium Corp. | CBQ |
| Jul 17, 1991 | K903237 | CARDIOCAP CMX-104 MONITOR Datex Division Instrumentarium Corp., FI | DXN |
| Jun 17, 1991 | K905754 | CAPNOMAC ULTIMA ANESTHESIA MONITOR Datex Division Instrumentarium Corp., FI | CBS |
| May 28, 1991 | K905140 | SATLITE PLUS PULSE OXIMETER Datex Division Instrumentarium Corp., FI | DQA |
| May 7, 1991 | K910620 | CARDIOCAP DR-124 RECORDER Datex Division Instrumentarium Corp., FI | DRG |
| Jan 23, 1991 | K903104 | CAPNOMAC ULTIMA (TM) ANESTHESIA MONITOR Datex Division Instrumentarium Corp., FI | CBQ |
| Sep 5, 1990 | K896652 | CAPNOMAC ULTIMA(TM) ANESTHESIA MONITOR Datex Division Instrumentarium Corp., FI | CCK |
| Jul 6, 1990 | K902493 | CARDIOCAP II CG-2GS, 2G, 1GS, 1G, 2CG, CS MONITOR Datex Division Instrumentarium Corp., FI | DRI |
| Jul 6, 1990 | K902492 | CARDIOCAP II MONITORS: CH, CH-2, CH-S, CH-2S Datex Division Instrumentarium Corp., FI | DRI |
| Mar 8, 1990 | K896190 | CARDIOCAP(TM) CMX-104 MONITOR Datex Division Instrumentarium Corp., FI | DPS |
| Mar 6, 1990 | K897080 | CARDIOCAP(TM) CT-104 MONITOR Datex Division Instrumentarium Corp., FI | DRT |
| Nov 29, 1989 | K895780 | OSCAROXY(TM) GAS MONITOR AND PULSE OXIMETER Datex Division Instrumentarium Corp., FI | CCK |
| Aug 2, 1989 | K891076 | CAPNOMAC II(TM) ANESTHESIA MULTIGAS MONITOR Datex Division Instrumentarium Corp. | CCK |
| Jul 14, 1989 | K885058 | CARDIOCAP(TM) DR-104 REPORTER Datex Division Instrumentarium Corp., FI | DSF |
| Jun 6, 1989 | K884991 | CARDIOCAP CCK-104 KEYBOARD & CCP-104 GRAPHICS PRIN Datex Division Instrumentarium Corp., FI | BSZ |
| Mar 22, 1989 | K890753 | SATLITE TRANS PORTABLE PULSE OXIMETER Datex Division Instrumentarium Corp., FI | DQA |
| Dec 28, 1988 | K884955 | CARDIOCAP(TM) CM-104 MONITOR Datex Division Instrumentarium Corp., FI | DXN |
| Dec 27, 1988 | K884956 | CARDIOCAP(TM) CTO-104 MONITOR Datex Division Instrumentarium Corp., FI | DPS |
| Oct 28, 1988 | K883877 | BM-103 BATTERY MODULE Datex Division Instrumentarium Corp., FI | DQA |
| Oct 19, 1988 | K882885 | DATEX AIRWAY MONITOR Datex Division Instrumentarium Corp., FI | CCK |
| Oct 19, 1988 | K882748 | NORMOCAP 200 CAPNOMETER Datex Division Instrumentarium Corp., FI | CCK |
| Jul 28, 1988 | K882093 | CARDIOCAP(TM) CMO-104 MONITOR Datex Division Instrumentarium Corp., FI | DSK |
| Jul 18, 1988 | K881883 | SATLITE+/PB251+ PULSE OXIMETER Datex Division Instrumentarium Corp., FI | DQA |
| Dec 29, 1987 | K873859 | CARDIOCAP(TM) PULSE OXIMETRY MODULE COS-104 Datex Division Instrumentarium Corp., FI | DQA |
| Sep 14, 1987 | K872760 | OSCAR(TM) PB255 OXIMETER CAPNOMETER Datex Division Instrumentarium Corp., FI | CCK |
| Jun 29, 1987 | K871826 | PB VIDEO DISPLAY TO PB251 PULSE OXIMETER UPGRADE Datex Division Instrumentarium Corp., FI | DQA |
| Mar 20, 1987 | K870621 | SATLITE/PB251 PULSE OXIMETER Datex Division Instrumentarium Corp., FI | DQA |
| Mar 17, 1987 | K864603 | DELTATRAC(TM) METABOLIC MONITOR Datex Division Instrumentarium Corp. | BZL |
| Sep 24, 1986 | K862455 | MODIFIED CARDIOCAP MONITOR Datex Division Instrumentarium Corp. | DSK |
| Sep 3, 1986 | K863248 | PB GRAPHICS PRINTER AND PB VIDEO DISPLAY Datex Division Instrumentarium Corp., FI | CBQ |
| May 2, 1986 | K861474 | PB253 TO PB254 IR - SPECTROMETER UPGRADE KIT Datex Division Instrumentarium Corp., FI | CBQ |
| Apr 4, 1986 | K861213 | PB 254 IR - SPECTROMETER Datex Division Instrumentarium Corp., FI | CCK |
Newest 50 of 55.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||