Clearance Summary
ULTepap Expiratory Positive Airway Pressure (EPAP) Device received FDA 510(k) clearance under submission number K191728, sponsored by Bryggs Medical, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2020-02-21.
- Submission: K191728
- Applicant / Sponsor: Bryggs Medical, LLC
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.5570
- Decision date: 2020-02-21
Classification & Regulation
This clearance is catalogued under FDA product code OHP and 21 CFR 872.5570, within the Dental review panel as a Class II device.