510(k) K111549
- Device
- ATTUNE SLEEP APNEA SYSTEM
- Applicant
- APNICURE, INC.
- 510(k) number
- K111549
- Product code
- OZR
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2012-03-30
- Date received
- 2011-06-03
- Regulation
- 872.5570
- Classification name
- Intraoral Pressure Gradient Device
- Medical specialty
- Dental
- Review panel
- Anesthesiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- CHRIS DANIEL
- Address
- 900 Chesapeake Dr. Redwood City CA US 94063 94063
FDA Registration Numbers#
- 3017791238
- 3014674517
- 3008791915
Source Documents#
Other 510(k) Records For Product Code OZR #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K220907 | The iNAP One Sleep Therapy System | Somnics, Inc. | 2023-06-16 |
| K193460 | The iNAP One Sleep Therapy System | Somnice, Inc. | 2020-05-26 |
| K132003 | WINX SLEEP THERAPY SYSTEM | Apnicure, Inc. | 2014-06-13 |
| K130538 | WINX SLEEP THERAPY SYSTEM | Apnicure, Inc. | 2013-05-22 |
| K122130 | WINX SLEEP THERAPY SYSTEM | Apnicure, Inc. | 2012-10-31 |
Legacy Summary#
summary
FDA Review#
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