K931112 is an FDA 510(k) clearance for the MODEL PB3300 INTRA-ARTER BLOOD GAS MONIT SYS, MODI. This device is classified as a Analyzer, Ion, Hydrogen-ion (ph), Blood-phase, Indwelling (Class II - Special Controls, product code CBZ).
Submitted by Puritan Bennett Corp. (Carlsbad, US). The FDA issued a Cleared decision on June 1, 1993, 89 days after receiving the submission on March 4, 1993.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.1170.
| 510(k) Number | K931112 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 04, 1993 |
| Decision Date | June 01, 1993 |
| Days to Decision | 89 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Statement |
| Product Code | CBZ — Analyzer, Ion, Hydrogen-ion (ph), Blood-phase, Indwelling |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.1170 |