CCE — Analyzer, Gas, Oxygen, Partial Pressure, Blood-Phase, Indwelling Class II
FDA product code CCE covers "Analyzer, Gas, Oxygen, Partial Pressure, Blood-Phase, Indwelling", a Class II medical device regulated under 21 CFR 868.1200. Submissions are reviewed by the Anesthesiology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- CCE
- Device Class
- Class II
- Regulation Number
- 868.1200
- Submission Type
- Review Panel
- AN
- Medical Specialty
- Anesthesiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K935778 | via medical | VIA 1-01 INFUSION PUMP/BLOOD CHEMISTRY SYSTEM | December 5, 1996 |
| K912145 | s and w medico teknik | SYSTEM ATHENA-PRODUCT ENHANCEMENTS, ANESTHESIA | May 5, 1992 |
| K910453 | baxter healthcare | TOPS NEEDLE TIP PROBE & PVC TIP PROBE | August 13, 1991 |
| K905397 | puritan bennett | PB3200 INTRA-ARTERIAL BLOOD GAS MONITORING SYSTEM | May 14, 1991 |
| K896311 | optex biomedical | OPTEX BLOOD GAS MONITORING SYSTEM | January 3, 1990 |
| K890624 | baxter healthcare | TISSUE OXYGEN MONITOR SYSTEM, MODEL II | December 22, 1989 |
| K895150 | shiley | CONTINUCATH 1000 INTRAVASCULAR OXYGEN MONITORING | November 28, 1989 |
| K895149 | shiley | NEOCATH 1000 UMBILICAL ARTERY OXYGEN MONITORING SY | November 28, 1989 |
| K884063 | c.r. bard | BARD ABG 100 INTRAVASCULAR OXYGEN MONITOR SYSTEM | December 16, 1988 |
| K875225 | ohmeda medical | UMBILICAL ARTERY OXYGEN SENSOR | March 4, 1988 |
| K872896 | american bentley | UMBILICAL ARTERY OXYGEN PROBE MODEL UAP-100 | February 12, 1988 |
| K872125 | c.r. bard | BARD ABG 100 INTRAVASCULAR OXYGEN MONITOR. SYSTEM | December 11, 1987 |
| K860808 | orange medical instruments | CONTINUCATH | March 13, 1986 |
| K860106 | american bentley | OXYGEN MONITOR NO. OM-100, OXYGEN PROBE NO. OP-100 | February 26, 1986 |
| K853786 | american bentley | OXYGEN MONITOR OM-100 & OXYGEN PROBE OP-100 | October 16, 1985 |
| K843912 | cardiovascular devices | INTRAVASCULAR BLOOD GAS SYSTEM | January 10, 1985 |
| K840102 | m. d. software | ARTERIAL BLOOD GAS INTERPRETATION PROG | February 4, 1984 |
| K832793 | orange medical instruments | NEOCATH 1000 W/HEPCOTE | September 26, 1983 |
| K811071 | g.d. searle and | VENOUS OXYGEN PROBE | May 5, 1981 |
| K781271 | roche medical electronics | MONITOR, PO2, INTRAVASCULAR | October 12, 1978 |