Analyzer, Gas, Oxygen, Partial Pressure, Blood-Phase, Indwelling
FDA product code CCE · Class II (moderate risk) · 21 CFR 868.1200 · Anesthesiology
23510(k) clearances
0PMA approvals
0recalls
Manufacturers
- American Bentley 3
- Sherwood Medical Industries 2
- Orange Medical Instruments, Inc. 2
- C.R. Bard, Inc. 2
- Shiley, Inc. 2
- Baxter Healthcare Corp 2
- Will Ross Co. 1
- Roche Medical Electronics, Inc. 1
- G.D. Searle and Co. 1
- M. D. Software, Inc. 1
- Cardiovascular Devices, Inc. 1
- Ohmeda Medical 1
- Optex Biomedical 1
- Puritan Bennett Corp. 1
- S & W Medico Teknik 1
- Via Medical Corp. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K935778 | Via 1-01 Infusion Pump/Blood Chemistry SystemCCE · Traditional | Via Medical Corp. | 12/05/1996SEKD |
| K912145 | System Athena-Product Enhancements, AnesthesiaCCE · Traditional | S & W Medico Teknik | 05/05/1992SE |
| K910453 | Tops Needle Tip Probe & PVC Tip ProbeCCE · Traditional | Baxter Healthcare Corp | 08/13/1991SE |
| K905397 | PB3200 Intra-Arterial Blood Gas Monitoring SystemCCE · Traditional | Puritan Bennett Corp. | 05/14/1991SE |
| K896311 | Optex Blood Gas Monitoring SystemCCE · Traditional | Optex Biomedical | 01/03/1990SE |
| K890624 | Tissue Oxygen Monitor System, Model IICCE · Traditional | Baxter Healthcare Corp | 12/22/1989SE |
| K895150 | Continucath 1000 Intravascular Oxygen MonitoringCCE · Traditional | Shiley, Inc. | 11/28/1989SE |
| K895149 | Neocath 1000 Umbilical Artery Oxygen Monitoring SyCCE · Traditional | Shiley, Inc. | 11/28/1989SE |
| K884063 | Bard Abg 100 Intravascular Oxygen Monitor SystemCCE · Traditional | C.R. Bard, Inc. | 12/16/1988SE |
| K875225 | Umbilical Artery Oxygen SensorCCE · Traditional | Ohmeda Medical | 03/04/1988SE |
| K872896 | Umbilical Artery Oxygen Probe Model UAP-100CCE · Traditional | American Bentley | 02/12/1988SE |
| K872125 | Bard Abg 100 Intravascular Oxygen Monitor. SystemCCE · Traditional | C.R. Bard, Inc. | 12/11/1987SE |
| K860808 | ContinucathCCE · Traditional | Orange Medical Instruments, Inc. | 03/13/1986SE |
| K860106 | Oxygen Monitor No. OM-100, Oxygen Probe No. OP-100CCE · Traditional | American Bentley | 02/26/1986SE |
| K853786 | Oxygen Monitor OM-100 & Oxygen Probe OP-100CCE · Traditional | American Bentley | 10/16/1985SE |
| K843912 | Intravascular Blood Gas SystemCCE · Traditional | Cardiovascular Devices, Inc. | 01/10/1985SE |
| K840102 | Arterial Blood Gas Interpretation ProgCCE · Traditional | M. D. Software, Inc. | 02/04/1984SE |
| K832793 | Neocath 1000 W/HepcoteCCE · Traditional | Orange Medical Instruments, Inc. | 09/26/1983SE |
| K811071 | Venous Oxygen ProbeCCE · Traditional | G.D. Searle and Co. | 05/05/1981SE |
| K781271 | Monitor, PO2, IntravascularCCE · Traditional | Roche Medical Electronics, Inc. | 10/12/1978SE |
| K780850 | Searle Neonatal Oxygen ProbeCCE · Traditional | Will Ross Co. | 08/23/1978SE |
| K771116 | Catheter, PO2, Intravasuclar, CitadelCCE · Traditional | Sherwood Medical Industries | 09/15/1977SE |
| K760350 | Monitor, Citadel Intravascular PO2CCE · Traditional | Sherwood Medical Industries | 10/29/1976SE |