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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 K110383
Device Name BABI*PLUS PRESSURE RELIEF MANIFOLD - 10CM H20, 12.5CM H20, 15CM H20
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 Number868.5905
Classification Product Code
BZD  
Date Received02/10/2011
Decision Date 08/01/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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