K903939 is an FDA 510(k) clearance for the PANDA HELIUM GAS ANALYZER. This device is classified as a Analyzer, Gas, Helium, Gaseous-phase (Class II - Special Controls, product code BSE).
Submitted by Medical Associated Services, Inc. (Hatfield, US). The FDA issued a Cleared decision on January 3, 1991, 129 days after receiving the submission on August 27, 1990.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.1640.
| 510(k) Number | K903939 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 27, 1990 |
| Decision Date | January 03, 1991 |
| Days to Decision | 129 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | — |
| Product Code | BSE — Analyzer, Gas, Helium, Gaseous-phase |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.1640 |