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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name ventilator, emergency, manual (resuscitator)
510(k) Number K112852
Device Name BABI PLUS NEONATAL RESUSCITATION BAG
Original Applicant
A PLUS MEDICAL
5431 avenida encinas
suite g
carlsbad,  CA  92008
Original Contact thomas c loescher
Regulation Number868.5915
Classification Product Code
BTM  
Date Received10/18/2011
Decision Date 01/13/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Anesthesiology
Review Advisory Committee Anesthesiology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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