The following data is part of a premarket notification filed by Renu Medical, Inc. with the FDA for Renu Reprocessed Nellcor Oxysensor, Models D-20 And I-20.
| Device ID | K063661 |
| 510k Number | K063661 |
| Device Name: | RENU REPROCESSED NELLCOR OXYSENSOR, MODELS D-20 AND I-20 |
| Classification | Oximeter, Reprocessed |
| Applicant | RENU MEDICAL, INC. 9800 EVERGREEN WAY Everett, WA 98204 |
| Contact | Bruce Pierson |
| Correspondent | Bruce Pierson RENU MEDICAL, INC. 9800 EVERGREEN WAY Everett, WA 98204 |
| Product Code | NLF |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-12-08 |
| Decision Date | 2007-05-25 |
| Summary: | summary |