Panels › Anesthesiology › Product code CCE · Class 2
Analyzer, Gas, Oxygen, Partial Pressure, Blood-Phase, Indwelling
Regulation 868.1200
0510(k)s in 12 months (23 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in CCE
| Company | 510(k)s | Recalls |
|---|---|---|
| American Bentley | 3 | 0 |
| Baxter Healthcare Corp | 2 | 0 |
| C.R. Bard, Inc. | 2 | 0 |
| Orange Medical Instruments, Inc. | 2 | 0 |
| Sherwood Medical Industries | 2 | 0 |
| Shiley, Inc. | 2 | 0 |
| Cardiovascular Devices, Inc. | 1 | 0 |
| G.D. Searle and Co. | 1 | 0 |
| M. D. Software, Inc. | 1 | 0 |
| Ohmeda Medical | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 5, 1996 | K935778 | VIA 1-01 INFUSION PUMP/BLOOD CHEMISTRY SYSTEM Via Medical Corp. | CCE |
| May 5, 1992 | K912145 | SYSTEM ATHENA-PRODUCT ENHANCEMENTS, ANESTHESIA S & W Medico Teknik, DK | CCE |
| Aug 13, 1991 | K910453 | TOPS NEEDLE TIP PROBE & PVC TIP PROBE Baxter Healthcare Corp | CCE |
| May 14, 1991 | K905397 | PB3200 INTRA-ARTERIAL BLOOD GAS MONITORING SYSTEM Puritan Bennett Corp. | CCE |
| Jan 3, 1990 | K896311 | OPTEX BLOOD GAS MONITORING SYSTEM Optex Biomedical | CCE |
| Dec 22, 1989 | K890624 | TISSUE OXYGEN MONITOR SYSTEM, MODEL II Baxter Healthcare Corp | CCE |
| Nov 28, 1989 | K895150 | CONTINUCATH 1000 INTRAVASCULAR OXYGEN MONITORING Shiley, Inc. | CCE |
| Nov 28, 1989 | K895149 | NEOCATH 1000 UMBILICAL ARTERY OXYGEN MONITORING SY Shiley, Inc. | CCE |
| Dec 16, 1988 | K884063 | BARD ABG 100 INTRAVASCULAR OXYGEN MONITOR SYSTEM C.R. Bard, Inc. | CCE |
| Mar 4, 1988 | K875225 | UMBILICAL ARTERY OXYGEN SENSOR Ohmeda Medical | CCE |
| Feb 12, 1988 | K872896 | UMBILICAL ARTERY OXYGEN PROBE MODEL UAP-100 American Bentley | CCE |
| Dec 11, 1987 | K872125 | BARD ABG 100 INTRAVASCULAR OXYGEN MONITOR. SYSTEM C.R. Bard, Inc. | CCE |
| Mar 13, 1986 | K860808 | CONTINUCATH Orange Medical Instruments, Inc., GB | CCE |
| Feb 26, 1986 | K860106 | OXYGEN MONITOR NO. OM-100, OXYGEN PROBE NO. OP-100 American Bentley | CCE |
| Oct 16, 1985 | K853786 | OXYGEN MONITOR OM-100 & OXYGEN PROBE OP-100 American Bentley | CCE |
| Jan 10, 1985 | K843912 | INTRAVASCULAR BLOOD GAS SYSTEM Cardiovascular Devices, Inc. | CCE |
| Feb 4, 1984 | K840102 | ARTERIAL BLOOD GAS INTERPRETATION PROG M. D. Software, Inc. | CCE |
| Sep 26, 1983 | K832793 | NEOCATH 1000 W/HEPCOTE Orange Medical Instruments, Inc. | CCE |
| May 5, 1981 | K811071 | VENOUS OXYGEN PROBE G.D. Searle and Co. | CCE |
| Oct 12, 1978 | K781271 | MONITOR, PO2, INTRAVASCULAR Roche Medical Electronics, Inc. | CCE |
| Aug 23, 1978 | K780850 | SEARLE NEONATAL OXYGEN PROBE Will Ross Co. | CCE |
| Sep 15, 1977 | K771116 | CATHETER, PO2, INTRAVASUCLAR, CITADEL Sherwood Medical Industries | CCE |
| Oct 29, 1976 | K760350 | MONITOR, CITADEL INTRAVASCULAR PO2 Sherwood Medical Industries | CCE |
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