ULTepap Expiratory Positive Airway Pressure (EPAP) Device
FDA 510(k) clearance K191728 · decided 2020-02-21
Clearance details
- K-number
- K191728
- Device name
- ULTepap Expiratory Positive Airway Pressure (EPAP) Device
- Applicant
- Bryggs Medical, LLC
- Decision
- Substantially Equivalent
- Date received
- 2019-06-27
- Decision date
- 2020-02-21
- Days to decision
- 239 days
- Clearance type
- Traditional
- Product code
- OHP
- Device class
- 2
- Regulation number
- 872.5570
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Avon, OH, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Bongo (K180619) | Innomed Healthscience, Inc. | 2018-08-16 |
| PROVENT PROFESSIONAL SLEEP APNEA THERAPY (PROVENT 80); PROVENT PROFESSIONAL SLEEP APNEA THERAPY (PROVENT 50) (K102404) | Ventus Medical, Inc. | 2010-12-02 |
| PROVENT PROFESSIONAL SLEEP APNEA THERAPY (K090398) | Ventus Medical, Inc. | 2009-04-03 |
| PROVENT NASAL DILATOR, MODEL BR2 (K071560) | Ventus Medical, Inc. | 2008-02-08 |
Recalls involving this device
No recalls on record reference this clearance.