K905397 is an FDA 510(k) clearance for the PB3200 INTRA-ARTERIAL BLOOD GAS MONITORING SYSTEM. This device is classified as a Analyzer, Gas, Oxygen, Partial Pressure, Blood-phase, Indwelling (Class II - Special Controls, product code CCE).
Submitted by Puritan Bennett Corp. (Overland Park, US). The FDA issued a Cleared decision on May 14, 1991, 165 days after receiving the submission on November 30, 1990.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.1200.
| 510(k) Number | K905397 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 30, 1990 |
| Decision Date | May 14, 1991 |
| Days to Decision | 165 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 |