The following data is part of a premarket notification filed by Edwards Lifesciences, Llc. with the FDA for Presep Oligon Oximetry Catheters.
| Device ID | K060093 |
| 510k Number | K060093 |
| Device Name: | PRESEP OLIGON OXIMETRY CATHETERS |
| Classification | Catheter, Oximeter, Fiber-optic |
| 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 | DQE |
| CFR Regulation Number | 870.1230 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-01-12 |
| Decision Date | 2006-04-28 |
| Summary: | summary |