The iNAP One Sleep Therapy System
FDA 510(k) clearance K193460 · decided 2020-05-26
Clearance details
- K-number
- K193460
- Device name
- The iNAP One Sleep Therapy System
- Applicant
- Somnice, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2019-12-16
- Decision date
- 2020-05-26
- Days to decision
- 162 days
- Clearance type
- Traditional
- Product code
- OZR
- Device class
- 2
- Regulation number
- 872.5570
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Hsinchu County, TW
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| The iNAP One Sleep Therapy System (K220907) | Somnics, Inc. | 2023-06-16 |
| WINX SLEEP THERAPY SYSTEM (K132003) | Apnicure, Inc. | 2014-06-13 |
| WINX SLEEP THERAPY SYSTEM (K130538) | Apnicure, Inc. | 2013-05-22 |
| WINX SLEEP THERAPY SYSTEM (K122130) | Apnicure, Inc. | 2012-10-31 |
| ATTUNE SLEEP APNEA SYSTEM (K111549) | Apnicure, Inc. | 2012-03-30 |
Recalls involving this device
No recalls on record reference this clearance.