The following data is part of a De Novo classification by Vapotherm, Inc. with the FDA for Precision Flow® Hvni.
| DeNovo ID | DEN170001 |
| Device Name: | Precision Flow® HVNI |
| Classification | High Flow/high Velocity Humidified Oxygen Delivery Device |
| Applicant | VAPOTHERM, INC. 22 Industrial Dr. Exeter, NH 03833 |
| Contact | Som Kovvuri |
| Product Code | QAV |
| CFR Regulation Number | 868.5454 [🔎] |
| Decision | Granted (DENG) |
| 510(k) Premarket Notification | Device Classification Under Section 513(f)(2)(de Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin |
| Review Advisory Board | Anesthesiology |
| Classification Advisory | Anesthesiology |
| Type | Direct |
| Date Received | 2017-01-03 |
| Decision Date | 2018-04-10 |
| FDA Review | Decision Summary |
| Reclassification Order: | Reclassification Order |