510(k) DEN170089
- Device
- Curve Positive Airway Pressure System
- Applicant
- Fresca Medical
- 510(k) number
- DEN170089
- Product code
- QBY
- Decision
- Unknown (DENG)
- Decision date
- 2018-06-05
- Date received
- 2017-12-14
- Regulation
- 868.5273
- Classification name
- Positive Airway Pressure System
- Medical specialty
- Anesthesiology
- Review panel
- Anesthesiology
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Mary Lou Mooney
- Address
- 1291 Puerta Del Sol Suite #200 San Clemente CA US 92673 92673
FDA Registration Numbers#
- 3020460367
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code QBY#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K200698 | Somnera System | Fresca Medical, Inc. | 2020-06-29 |