The following data is part of a premarket notification filed by Renu Medical, Inc. with the FDA for Renu Medical Reprocessed Oximax Sensors: Adult, Pediatric, Infant And Neonate.
| Device ID | K111773 |
| 510k Number | K111773 |
| Device Name: | RENU MEDICAL REPROCESSED OXIMAX SENSORS: ADULT, PEDIATRIC, INFANT AND NEONATE |
| Classification | Oximeter, Reprocessed |
| Applicant | RENU MEDICAL, INC. 9800 EVERGREEN WAY Everett, WA 98204 |
| Contact | L Bruce Pierson |
| Correspondent | L 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 | 2011-06-23 |
| Decision Date | 2011-11-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10861317020566 | K111773 | 000 |
| 10861317020559 | K111773 | 000 |
| 10861317020542 | K111773 | 000 |
| 10861317020535 | K111773 | 000 |
| 10816317020566 | K111773 | 000 |
| 10816317020559 | K111773 | 000 |
| 10816317020542 | K111773 | 000 |
| 10816317020535 | K111773 | 000 |