K983864 is an FDA 510(k) clearance for the ETCO2 VITAL SIGNS 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. (Rehovot, IL). The FDA issued a Cleared decision on October 8, 1999, 340 days after receiving the submission on November 2, 1998.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.1400.
| 510(k) Number | K983864 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 02, 1998 |
| Decision Date | October 08, 1999 |
| Days to Decision | 340 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | CCK — Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.1400 |