DEN170001 is an FDA 510(k) submission for the Precision Flow® HVNI. This device is classified as a High Flow/high Velocity Humidified Oxygen Delivery Device (Class II - Special Controls, product code QAV).
Submitted by Vapotherm, Inc. (Exeter, US). The FDA issued a Not Cleared (DENG) decision on April 10, 2018.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5454. Intended To Deliver High Flow And/or High Velocity Oxygen With Humidification..
| 510(k) Number | DEN170001 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | January 03, 2017 |
| Decision Date | April 10, 2018 |
| Days to Decision | 462 days |
| Submission Type | Direct |
| Review Panel | Anesthesiology (AN) |
| Summary | - |
| Product Code | QAV - High Flow/high Velocity Humidified Oxygen Delivery Device |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5454 |
| Definition | Intended To Deliver High Flow And/or High Velocity Oxygen With Humidification. |