The following data is part of a premarket notification filed by Renu Medical, Inc. with the FDA for Renu Medical Oximetry Sensor, Adult, Ped, Inf,neo.
| Device ID | K081927 |
| 510k Number | K081927 |
| Device Name: | RENU MEDICAL OXIMETRY SENSOR, ADULT, PED, INF,NEO |
| 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 | 2008-07-07 |
| Decision Date | 2009-02-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10861317020511 | K081927 | 000 |
| 10816317023499 | K081927 | 000 |
| 10816317023970 | K081927 | 000 |
| 10816317020443 | K081927 | 000 |
| 10816317020450 | K081927 | 000 |
| 10816317020467 | K081927 | 000 |
| 10816317020474 | K081927 | 000 |
| 10816317020481 | K081927 | 000 |
| 10816317020498 | K081927 | 000 |
| 10816317020504 | K081927 | 000 |
| 10816317020511 | K081927 | 000 |
| 10861317020443 | K081927 | 000 |
| 10861317020450 | K081927 | 000 |
| 10861317020467 | K081927 | 000 |
| 10861317020474 | K081927 | 000 |
| 10861317020481 | K081927 | 000 |
| 10861317020498 | K081927 | 000 |
| 10861317020504 | K081927 | 000 |
| 10816317024106 | K081927 | 000 |