K191728 is an FDA 510(k) clearance for the ULTepap Expiratory Positive Airway Pressure (EPAP) Device. This device is classified as a Expiratory Resistance Valve, Intranasal, For Obstructive Sleep Apnea (Class II - Special Controls, product code OHP).
Submitted by Bryggs Medical, LLC (Avon, US). The FDA issued a Cleared decision on February 21, 2020, 239 days after receiving the submission on June 27, 2019.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 872.5570. Intranasal Device That Creates Expiratory Resistance For The Treatment Of Obstructive Sleep Apnea..
| 510(k) Number | K191728 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 27, 2019 |
| Decision Date | February 21, 2020 |
| Days to Decision | 239 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | OHP - Expiratory Resistance Valve, Intranasal, For Obstructive Sleep Apnea |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.5570 |
| Definition | Intranasal Device That Creates Expiratory Resistance For The Treatment Of Obstructive Sleep Apnea. |