K043065 is an FDA 510(k) clearance for the VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR, MODELS MIHM1 AND MIHM1P. This device is classified as a Transducer, Blood-pressure, Extravascular (Class II - Special Controls, product code DRS).
Submitted by Edwards Lifesciences, LLC (Irvine, US). The FDA issued a Cleared decision on January 26, 2005, 82 days after receiving the submission on November 5, 2004.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2850.
| 510(k) Number | K043065 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 05, 2004 |
| Decision Date | January 26, 2005 |
| Days to Decision | 82 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DRS — Transducer, Blood-pressure, Extravascular |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2850 |