The following data is part of a premarket notification filed by Mennen Medical, Inc. with the FDA for Capnomed 100 Stand-alone Etco2 Module.
| Device ID | K920915 |
| 510k Number | K920915 |
| Device Name: | CAPNOMED 100 STAND-ALONE ETCO2 MODULE |
| Classification | Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
| Applicant | MENNEN MEDICAL, INC. 10123 MAIN ST. Clarence, NY 14031 |
| Contact | Ronald A Brandt |
| Correspondent | Ronald A Brandt MENNEN MEDICAL, INC. 10123 MAIN ST. Clarence, NY 14031 |
| Product Code | CCK |
| CFR Regulation Number | 868.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-02-27 |
| Decision Date | 1993-03-23 |