K131765 is an FDA 510(k) clearance for the ECOM ENDOTRACHEAL CARDIAC OUTPUT MONITOR SYSTEM. This device is classified as a Plethysmograph, Impedance (Class II - Special Controls, product code DSB).
Submitted by Conmed Corporation (Utica, US). The FDA issued a Cleared decision on December 20, 2013, 186 days after receiving the submission on June 17, 2013.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2770.
| 510(k) Number | K131765 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 17, 2013 |
| Decision Date | December 20, 2013 |
| Days to Decision | 186 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DSB — Plethysmograph, Impedance |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2770 |