Somnera System
FDA 510(k) clearance K200698 · decided 2020-06-29
Clearance details
- K-number
- K200698
- Device name
- Somnera System
- Applicant
- Fresca Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2020-03-17
- Decision date
- 2020-06-29
- Days to decision
- 104 days
- Clearance type
- Traditional
- Product code
- QBY
- Device class
- 2
- Regulation number
- 868.5273
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- San Clemente, CA, US
- 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 |
|---|---|---|
| Curve Positive Airway Pressure System (DEN170089) | Fresca Medical | 2018-06-05 |
Recalls involving this device
No recalls on record reference this clearance.