FDA Product Code
FDA Product Code OHP — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Dental
- 21 CFR Citation
- 872.5570
510(k) Clearances — 5 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K191728 | ULTepap Expiratory Positive Airway Pressure (EPAP) Device | Bryggs Medical, LLC | 2020-02-21 | Traditional | PDF ↗ |
| K180619 | Bongo | Innomed Healthscience, Inc. | 2018-08-16 | Traditional | PDF ↗ |
| K102404 | PROVENT PROFESSIONAL SLEEP APNEA THERAPY (PROVENT 80); PROVENT PROFESSIONAL SLEEP APNEA THERAPY (PROVENT 50) | Ventus Medical, Inc. | 2010-12-02 | Traditional | PDF ↗ |
| K090398 | PROVENT PROFESSIONAL SLEEP APNEA THERAPY | Ventus Medical, Inc. | 2009-04-03 | Traditional | PDF ↗ |
| K071560 | PROVENT NASAL DILATOR, MODEL BR2 | Ventus Medical, Inc. | 2008-02-08 | Traditional | PDF ↗ |
Product code OHP · Class II · Dental. Data: openFDA.