K884063 is an FDA 510(k) clearance for the BARD ABG 100 INTRAVASCULAR OXYGEN MONITOR SYSTEM. This device is classified as a Analyzer, Gas, Oxygen, Partial Pressure, Blood-phase, Indwelling (Class II - Special Controls, product code CCE).
Submitted by C.R. Bard, Inc. (Tewksbury, US). The FDA issued a Cleared decision on December 16, 1988, 81 days after receiving the submission on September 26, 1988.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.1200.
| 510(k) Number | K884063 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 26, 1988 |
| Decision Date | December 16, 1988 |
| Days to Decision | 81 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | — |
| Product Code | CCE — Analyzer, Gas, Oxygen, Partial Pressure, Blood-phase, Indwelling |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.1200 |