K920915 is an FDA 510(k) clearance for the CAPNOMED 100 STAND-ALONE ETCO2 MODULE. This device is classified as a Analyzer, Gas, Carbon-dioxide, Gaseous-phase (Class II - Special Controls, product code CCK).
Submitted by Mennen Medical, Inc. (Clarence, US). The FDA issued a Cleared decision on March 23, 1993, 390 days after receiving the submission on February 27, 1992.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.1400.
| 510(k) Number | K920915 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 27, 1992 |
| Decision Date | March 23, 1993 |
| Days to Decision | 390 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Statement |
| Product Code | CCK — Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.1400 |