K032491 is an FDA 510(k) clearance for the ECOM CV4 ENDOTRACHEAL CARDIAC OUTPUT MONITOR. This device is classified as a Plethysmograph, Impedance (Class II - Special Controls, product code DSB).
Submitted by Imagyn Medical Technologies, Inc. (Irvine, US). The FDA issued a Cleared decision on September 4, 2003, 23 days after receiving the submission on August 12, 2003.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2770.
| 510(k) Number | K032491 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Abbreviated 510(k) (SESU) |
| Date Received | August 12, 2003 |
| Decision Date | September 04, 2003 |
| Days to Decision | 23 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DSB — Plethysmograph, Impedance |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2770 |