K955816 is an FDA 510(k) clearance for the VIGILANCE CONTINUOUS CARDIAC OUTPUT/OXIMETRY (CCO/SVO2) MONITOR. This device is classified as a Catheter, Flow Directed (Class II - Special Controls, product code DYG).
Submitted by Baxter Healthcare Corp (Irvine, US). The FDA issued a Cleared decision on May 6, 1997, 497 days after receiving the submission on December 26, 1995.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1240.
| 510(k) Number | K955816 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 26, 1995 |
| Decision Date | May 06, 1997 |
| Days to Decision | 497 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DYG — Catheter, Flow Directed |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1240 |