K942593 is an FDA 510(k) clearance for the OXYCHEK OXYGEN ANALYZER. This device is classified as a Analyzer, Gas, Oxygen, Gaseous-phase (Class II - Special Controls, product code CCL).
Submitted by Nidek Medical Products, Inc. (Birmingham, US). The FDA issued a Cleared decision on May 3, 1995, 336 days after receiving the submission on June 1, 1994.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.1720.
| 510(k) Number | K942593 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 01, 1994 |
| Decision Date | May 03, 1995 |
| Days to Decision | 336 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Statement |
| Product Code | CCL - Analyzer, Gas, Oxygen, Gaseous-phase |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.1720 |