Cereve Sleep System
FDA 510(k) clearance DEN140032 · decided 2016-05-13
Clearance details
- K-number
- DEN140032
- Device name
- Cereve Sleep System
- Applicant
- Cereve, Inc.
- Decision
- Unknown
- Date received
- 2014-10-20
- Decision date
- 2016-05-13
- Days to decision
- 571 days
- Clearance type
- Direct
- Product code
- PLU
- Device class
- 2
- Regulation number
- 882.5700
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Oakmont, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.