510(k) K200698
K200698 is an FDA 510(k) premarket notification submitted by Fresca Medical, Inc. for the device "Somnera System". The FDA issued a decision of Substantially Equivalent on June 29, 2020. The device falls under product code QBY (Positive Airway Pressure System), a Class II device regulated under 21 CFR 868.5273. Fresca Medical, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 29, 2020
- Date Received
- March 17, 2020
- Clearance Type
- Traditional
- 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
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.