FDA Product Code
FDA Product Code OZR — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Dental
- 21 CFR Citation
- 872.5570
510(k) Clearances — 6 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K220907 | The iNAP One Sleep Therapy System | Somnics, Inc. | 2023-06-16 | Traditional | PDF ↗ |
| K193460 | The iNAP One Sleep Therapy System | Somnice, Inc. | 2020-05-26 | Traditional | PDF ↗ |
| K132003 | WINX SLEEP THERAPY SYSTEM | Apnicure, Inc. | 2014-06-13 | Traditional | PDF ↗ |
| K130538 | WINX SLEEP THERAPY SYSTEM | Apnicure, Inc. | 2013-05-22 | Special | PDF ↗ |
| K122130 | WINX SLEEP THERAPY SYSTEM | Apnicure, Inc. | 2012-10-31 | Special | PDF ↗ |
| K111549 | ATTUNE SLEEP APNEA SYSTEM | Apnicure, Inc. | 2012-03-30 | Traditional | PDF ↗ |
Product code OZR · Class II · Dental. Data: openFDA.