510(k) DEN170089
DEN170089 is an FDA 510(k) premarket notification submitted by Fresca Medical for the device "Curve Positive Airway Pressure System". The FDA issued a decision of De Novo granted on Jun 5, 2018. The device falls under product code QBY (Positive Airway Pressure System), a Class II device regulated under 21 CFR 868.5273. Fresca Medical has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- DENG (De Novo granted)
- Decision Date
- Jun 5, 2018
- Date Received
- Dec 14, 2017
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Positive Airway Pressure System
- Device Class
- Class II
- Regulation Number
- 868.5273
- Review Panel
- AN
- Submission Type
- 510(k)
A positive airway pressure delivery system is a prescription noninvasive ventilatory device that delivers expiratory positive airway pressure for patients suffering from obstructive sleep apnea. The system also provides positive airway pressure during incipient apnea. The system may include a dedicated flow generator and a patient interface.