The following data is part of a premarket notification filed by Mennen Medical, Inc. with the FDA for Etco2 Vital Signs Module.
| Device ID | K983864 |
| 510k Number | K983864 |
| Device Name: | ETCO2 VITAL SIGNS MODULE |
| Classification | Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
| Applicant | MENNEN MEDICAL, INC. KIRYAT WEIZMANN SCIENCE PARK P.O. BOX 102 Rehovot, IL 76100 |
| Contact | Kenneth Raichman |
| Correspondent | Kenneth Raichman MENNEN MEDICAL, INC. KIRYAT WEIZMANN SCIENCE PARK P.O. BOX 102 Rehovot, IL 76100 |
| Product Code | CCK |
| CFR Regulation Number | 868.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-11-02 |
| Decision Date | 1999-10-08 |
| Summary: | summary |