OEMEDIC INTERNATIONAL INC. BESMED SINGLE USE ADULT, CHILD, INFANT MANUAL RESUSCITATOR WITH MASK & RESERVOIR


Device Classification Name

ventilator, emergency, manual (resuscitator)

510(k) Number K021442
Device Name OEMEDIC INTERNATIONAL INC. BESMED SINGLE USE ADULT, CHILD, INFANT MANUAL RESUSCITATOR WITH MASK & 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 07/30/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No