Analyzer, Gas, Oxygen, Partial Pressure, Blood-Phase, Indwelling
The Indwelling Blood-Phase Oxygen Partial Pressure Analyzer is an anesthesiology device that continuously measures the partial pressure of oxygen (pO2) in the bloodstream while remaining in contact with blood within the body, providing real-time oxygenation data for patient monitoring. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket notification. The product code is CCE, regulated under 21 CFR 868.1200, within the Anesthesiology medical specialty. This device is eligible for third-party review.
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Basic Information
- Product Code
- CCE
- Device Class
- FDA class 2
- Regulation Number
- 868.1200
- Medical Specialty
- Anesthesiology
- Review Panel
- AN
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 23 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K935778 | VIA 1-01 INFUSION PUMP/BLOOD CHEMISTRY SYSTEM | Dec 05, 1996 | Unknown | Via Medical Corp. |
| K912145 | SYSTEM ATHENA-PRODUCT ENHANCEMENTS, ANESTHESIA | May 05, 1992 | Substantially Equivalent | S & W Medico Teknik |
| K910453 | TOPS NEEDLE TIP PROBE & PVC TIP PROBE | Aug 13, 1991 | Substantially Equivalent | Baxter Healthcare Corp |
| K905397 | PB3200 INTRA-ARTERIAL BLOOD GAS MONITORING SYSTEM | May 14, 1991 | Substantially Equivalent | Puritan Bennett Corp. |
| K896311 | OPTEX BLOOD GAS MONITORING SYSTEM | Jan 03, 1990 | Substantially Equivalent | Optex Biomedical |
| K890624 | TISSUE OXYGEN MONITOR SYSTEM, MODEL II | Dec 22, 1989 | Substantially Equivalent | Baxter Healthcare Corp |
| K895150 | CONTINUCATH 1000 INTRAVASCULAR OXYGEN MONITORING | Nov 28, 1989 | Substantially Equivalent | Shiley, Inc. |
| K895149 | NEOCATH 1000 UMBILICAL ARTERY OXYGEN MONITORING SY | Nov 28, 1989 | Substantially Equivalent | Shiley, Inc. |
| K884063 | BARD ABG 100 INTRAVASCULAR OXYGEN MONITOR SYSTEM | Dec 16, 1988 | Substantially Equivalent | C.R. Bard, Inc. |
| K875225 | UMBILICAL ARTERY OXYGEN SENSOR | Mar 04, 1988 | Substantially Equivalent | Ohmeda Medical |
| K872896 | UMBILICAL ARTERY OXYGEN PROBE MODEL UAP-100 | Feb 12, 1988 | Substantially Equivalent | American Bentley |
| K872125 | BARD ABG 100 INTRAVASCULAR OXYGEN MONITOR. SYSTEM | Dec 11, 1987 | Substantially Equivalent | C.R. Bard, Inc. |
| K860808 | CONTINUCATH | Mar 13, 1986 | Substantially Equivalent | Orange Medical Instruments, Inc. |
| K860106 | OXYGEN MONITOR NO. OM-100, OXYGEN PROBE NO. OP-100 | Feb 26, 1986 | Substantially Equivalent | American Bentley |
| K853786 | OXYGEN MONITOR OM-100 & OXYGEN PROBE OP-100 | Oct 16, 1985 | Substantially Equivalent | American Bentley |
| K843912 | INTRAVASCULAR BLOOD GAS SYSTEM | Jan 10, 1985 | Substantially Equivalent | Cardiovascular Devices, Inc. |
| K840102 | ARTERIAL BLOOD GAS INTERPRETATION PROG | Feb 04, 1984 | Substantially Equivalent | M. D. Software, Inc. |
| K832793 | NEOCATH 1000 W/HEPCOTE | Sep 26, 1983 | Substantially Equivalent | Orange Medical Instruments, Inc. |
| K811071 | VENOUS OXYGEN PROBE | May 05, 1981 | Substantially Equivalent | G.D. Searle and Co. |
| K781271 | MONITOR, PO2, INTRAVASCULAR | Oct 12, 1978 | Substantially Equivalent | Roche Medical Electronics, Inc. |
| K780850 | SEARLE NEONATAL OXYGEN PROBE | Aug 23, 1978 | Substantially Equivalent | Will Ross Co. |
| K771116 | CATHETER, PO2, INTRAVASUCLAR, CITADEL | Sep 15, 1977 | Substantially Equivalent | Sherwood Medical Industries |
| K760350 | MONITOR, CITADEL INTRAVASCULAR PO2 | Oct 29, 1976 | Substantially Equivalent | Sherwood Medical Industries |