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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
Predetermined Change
Control Plan Authorized		 No
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