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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
Applicant
A PLUS MEDICAL
5431 AVENIDA ENCINAS
SUITE G
CARLSBAD,  CA  92008
Applicant Contact THOMAS C LOESCHER
Correspondent
A PLUS MEDICAL
5431 AVENIDA ENCINAS
SUITE G
CARLSBAD,  CA  92008
Correspondent Contact THOMAS C LOESCHER
Regulation Number868.5915
Classification Product Code
BTM  
Date Received10/18/2011
Decision Date 01/13/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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