Curve Positive Airway Pressure System
FDA 510(k) clearance DEN170089 · decided 2018-06-05
Clearance details
- K-number
- DEN170089
- Device name
- Curve Positive Airway Pressure System
- Applicant
- Fresca Medical
- Decision
- Unknown
- Date received
- 2017-12-14
- Decision date
- 2018-06-05
- Days to decision
- 173 days
- Clearance type
- Direct
- 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 |
|---|---|---|
| Somnera System (K200698) | Fresca Medical, Inc. | 2020-06-29 |
Recalls involving this device
No recalls on record reference this clearance.