PRECISION FLOW


Device Classification Name

humidifier, respiratory gas, (direct patient interface)

510(k) Number K072845
Device Name PRECISION FLOW
Applicant
VAPOTHERM, INC.
555 thirteenth street, nw
washington, 
DC 
21666

Applicant Contact jonathan s kahn
Correspondent
VAPOTHERM, INC.
555 thirteenth street, nw
washington, 
DC 
21666

Correspodent Contact jonathan s kahn
Regulation Number 868.5450
Classification Product Code
BTT  
Date Received 10/04/2007
Decision Date 07/17/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No