K954803 is an FDA 510(k) clearance for the BLOOD GAS MIXTURES. This device is classified as a Gas, Calibration (specified Concentration) (Class I - General Controls, product code BXK).
Submitted by Mittler Supply, Inc. (South Bend, US). The FDA issued a Cleared decision on January 25, 1996, 98 days after receiving the submission on October 19, 1995.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.6400.
| 510(k) Number | K954803 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 19, 1995 |
| Decision Date | January 25, 1996 |
| Days to Decision | 98 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Statement |
| Product Code | BXK — Gas, Calibration (specified Concentration) |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 868.6400 |