FLOWREST


Device Classification Name

humidifier, respiratory gas, (direct patient interface)

510(k) Number K103316
Device Name FLOWREST
Applicant
VAPOTHERM, INC.
198 log canoe circle
stevensville, 
MD 
21666

Applicant Contact gregory a whitney
Correspondent
VAPOTHERM, INC.
198 log canoe circle
stevensville, 
MD 
21666

Correspodent Contact gregory a whitney
Regulation Number 868.5450
Classification Product Code
BTT  
Date Received 11/10/2010
Decision Date 02/08/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No