CCE · Analyzer, Gas, Oxygen, Partial Pressure, Blood-Phase, Indwelling
Anesthesiology · 21 CFR 868.1200 · Class 2
Overview
| Product Code | CCE |
|---|---|
| Device Name | Analyzer, Gas, Oxygen, Partial Pressure, Blood-Phase, Indwelling |
| Regulation | 21 CFR 868.1200 |
| Device Class | Class 2 |
| Review Panel | Anesthesiology |
| 3rd-Party Reviewable | Yes |
Identification
An indwelling blood oxygen partial pressure (PO2 ) analyzer is a device that consists of a catheter-tip PO2 transducer (e.g., PO2 electrode) and that is used to measure, in vivo, the partial pressure of oxygen in blood to aid in determining the patient's circulatory, ventilatory, and metabolic status.
Classification Rationale
Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Indwelling Blood Gas Analyzers; Final Guidance for Industry and FDA.”
Special Controls
*Classification.* Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Indwelling Blood Gas Analyzers; Final Guidance for Industry and FDA.”
Recent Cleared Devices (20 of 23)
Showing 20 most recent of 23 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K935778 | VIA 1-01 INFUSION PUMP/BLOOD CHEMISTRY SYSTEM | Via Medical Corp. | Dec 5, 1996 | SEKD |
| K912145 | SYSTEM ATHENA-PRODUCT ENHANCEMENTS, ANESTHESIA | S & W Medico Teknik | May 5, 1992 | SESE |
| K910453 | TOPS NEEDLE TIP PROBE & PVC TIP PROBE | Baxter Healthcare Corp | Aug 13, 1991 | SESE |
| K905397 | PB3200 INTRA-ARTERIAL BLOOD GAS MONITORING SYSTEM | Puritan Bennett Corp. | May 14, 1991 | SESE |
| K896311 | OPTEX BLOOD GAS MONITORING SYSTEM | Optex Biomedical | Jan 3, 1990 | SESE |
| K890624 | TISSUE OXYGEN MONITOR SYSTEM, MODEL II | Baxter Healthcare Corp | Dec 22, 1989 | SESE |
| K895150 | CONTINUCATH 1000 INTRAVASCULAR OXYGEN MONITORING | Shiley, Inc. | Nov 28, 1989 | SESE |
| K895149 | NEOCATH 1000 UMBILICAL ARTERY OXYGEN MONITORING SY | Shiley, Inc. | Nov 28, 1989 | SESE |
| K884063 | BARD ABG 100 INTRAVASCULAR OXYGEN MONITOR SYSTEM | C.R. Bard, Inc. | Dec 16, 1988 | SESE |
| K875225 | UMBILICAL ARTERY OXYGEN SENSOR | Ohmeda Medical | Mar 4, 1988 | SESE |
| K872896 | UMBILICAL ARTERY OXYGEN PROBE MODEL UAP-100 | American Bentley | Feb 12, 1988 | SESE |
| K872125 | BARD ABG 100 INTRAVASCULAR OXYGEN MONITOR. SYSTEM | C.R. Bard, Inc. | Dec 11, 1987 | SESE |
| K860808 | CONTINUCATH | Orange Medical Instruments, Inc. | Mar 13, 1986 | SESE |
| K860106 | OXYGEN MONITOR NO. OM-100, OXYGEN PROBE NO. OP-100 | American Bentley | Feb 26, 1986 | SESE |
| K853786 | OXYGEN MONITOR OM-100 & OXYGEN PROBE OP-100 | American Bentley | Oct 16, 1985 | SESE |
| K843912 | INTRAVASCULAR BLOOD GAS SYSTEM | Cardiovascular Devices, Inc. | Jan 10, 1985 | SESE |
| K840102 | ARTERIAL BLOOD GAS INTERPRETATION PROG | M. D. Software, Inc. | Feb 4, 1984 | SESE |
| K832793 | NEOCATH 1000 W/HEPCOTE | Orange Medical Instruments, Inc. | Sep 26, 1983 | SESE |
| K811071 | VENOUS OXYGEN PROBE | G.D. Searle and Co. | May 5, 1981 | SESE |
| K781271 | MONITOR, PO2, INTRAVASCULAR | Roche Medical Electronics, Inc. | Oct 12, 1978 | SESE |
Top Applicants
- American Bentley — 3 clearances
- Baxter Healthcare Corp — 2 clearances
- C.R. Bard, Inc. — 2 clearances
- Orange Medical Instruments, Inc. — 2 clearances
- Sherwood Medical Industries — 2 clearances
