The following data is part of a premarket notification filed by Edwards Lifesciences, Llc. with the FDA for Vigileo Arterial Pressure Cardiac Output/oximetry Monitor, Models Mihm1 And Mihm1p.
| Device ID | K043065 |
| 510k Number | K043065 |
| Device Name: | VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR, MODELS MIHM1 AND MIHM1P |
| Classification | Transducer, Blood-pressure, Extravascular |
| Applicant | EDWARDS LIFESCIENCES, LLC. ONE EDWARDS WAY Irvine, CA 92614 |
| Contact | Jason Smith |
| Correspondent | Jason Smith EDWARDS LIFESCIENCES, LLC. ONE EDWARDS WAY Irvine, CA 92614 |
| Product Code | DRS |
| CFR Regulation Number | 870.2850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-11-05 |
| Decision Date | 2005-01-26 |
| Summary: | summary |