VAPOTHERM, MODEL 2000I


definition

Device Classification Name

humidifier, respiratory gas, (direct patient interface)

510(k) Number K000401
Device Name VAPOTHERM, MODEL 2000I
Original Applicant
VAPOTHERM, INC.
163 conduit st.
annapolis, 
MD 
21401

Original Contact william niland
Regulation Number 868.5450
Classification Product Code
BTT  
Date Received 02/07/2000
Decision Date 08/24/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls