The following data is part of a premarket notification filed by Bryggs Medical, Llc with the FDA for Ultepap Expiratory Positive Airway Pressure (epap) Device.
| Device ID | K191728 |
| 510k Number | K191728 |
| Device Name: | ULTepap Expiratory Positive Airway Pressure (EPAP) Device |
| Classification | Expiratory Resistance Valve, Intranasal, For Obstructive Sleep Apnea |
| Applicant | Bryggs Medical, LLC 34910 Commerce Way Avon, OH 44011 |
| Contact | Geoffrey Sleeper |
| Correspondent | Geoffrey Sleeper Bryggs Medical, LLC 34910 Commerce Way Avon, OH 44011 |
| Product Code | OHP |
| CFR Regulation Number | 872.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-06-27 |
| Decision Date | 2020-02-21 |