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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name ventilator, non-continuous (respirator)
510(k) Number K093716
Device Name BABI PLUS INFANT NASAL CANNULA SYSTEM
Applicant
A PLUS MEDICAL
5431 AVENIDA ENCINAS
SUITE G
CARLSBAD,  CA  92008
Applicant Contact TOM LOESCHER
Correspondent
A PLUS MEDICAL
5431 AVENIDA ENCINAS
SUITE G
CARLSBAD,  CA  92008
Correspondent Contact TOM LOESCHER
Regulation Number868.5905
Classification Product Code
BZD  
Date Received12/02/2009
Decision Date 05/13/2010
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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