SMART BAG MO


Device Classification Name

ventilator, emergency, manual (resuscitator)

510(k) Number K021328
Device Name SMART BAG MO
Original Applicant
O-TWO SYSTEMS INTERNATIONAL INC.
7575 kimbel st.
mississauga,ontario, 

CA

l5s 1c8

Original Contact kevin bowden
Regulation Number 868.5915
Classification Product Code
BTM  
Date Received 04/26/2002
Decision Date 06/26/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No