510(k) DEN170001
- Device
- Precision Flow® HVNI
- Applicant
- Vapotherm, Inc.
- 510(k) number
- DEN170001
- Product code
- QAV
- Decision
- Unknown (DENG)
- Decision date
- 2018-04-10
- Date received
- 2017-01-03
- Regulation
- 868.5454
- Classification name
- High Flow/High Velocity Humidified Oxygen Delivery Device
- Medical specialty
- Anesthesiology
- Review panel
- Anesthesiology
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- SOM KOVVURI
- Address
- 22 Industrial Dr. Exeter NH US 03833 03833
FDA Registration Numbers#
- 3015928685
- 9611451
- 3012971441
- 2085602
- 3008264065
- 3023209222
Source Documents#
510(k) summary PDF not indicated by FDA