The following data is part of a premarket notification filed by Edwards Lifesciences, Llc. with the FDA for Ew200 System (oxygen Saturation Monitoring System) And Presep Oximetry Catheter.
| Device ID | K060660 |
| 510k Number | K060660 |
| Device Name: | EW200 SYSTEM (OXYGEN SATURATION MONITORING SYSTEM) AND PRESEP OXIMETRY CATHETER |
| Classification | Computer, Diagnostic, Pre-programmed, Single-function |
| Applicant | EDWARDS LIFESCIENCES, LLC. ONE EDWARDS WAY Irvine, CA 92614 |
| Contact | Paula A Torrianni |
| Correspondent | Laura Danielson TUV AMERICA, INC. 1775 OLD HIGHWAY 8 New Brighton, MN 55112 -1891 |
| Product Code | DXG |
| CFR Regulation Number | 870.1435 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2006-03-13 |
| Decision Date | 2006-04-25 |
| Summary: | summary |