FDA 510(k) Application Details - DEN170001

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN170001
Device Name	Precision Flow« HVNI
Applicant	VAPOTHERM, INC. 22 INDUSTRIAL DR. EXETER, NH 03833 US Other 510(k) Applications for this Company
Contact	SOM KOVVURI Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QAV Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/03/2017
Decision Date	04/10/2018
Decision	DENG -
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review