OEMEDIC INTERNATIONAL INC. BESMED SILICONE ADULT, CHILD, INFANT MANUAL RESUSCITATOR WITH MASK AND RESERVOIR


Device Classification Name

ventilator, emergency, manual (resuscitator)

510(k) Number K021446
Device Name OEMEDIC INTERNATIONAL INC. BESMED SILICONE ADULT, CHILD, INFANT MANUAL RESUSCITATOR WITH MASK AND RESERVOIR
Original Applicant
OEMEDIC INTERNATIONAL, INC.
13 red fox ln.
littleton, 
CO 
80127

Original Contact kevin walls
Regulation Number 868.5915
Classification Product Code
BTM  
Date Received 05/06/2002
Decision Date 10/11/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No