FDA 510(k) Application Details - K110471

Device Classification Name Ventilator, Non-Continuous (Respirator)

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510(K) Number K110471
Device Name Ventilator, Non-Continuous (Respirator)
Applicant A PLUS MEDICAL
5431 AVENIDA ENCINAS
SUITE G
CARLSBAD, CA 92008 US
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Contact THOMAS C LOESCHER
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Regulation Number 868.5905

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Classification Product Code BZD
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Date Received 02/18/2011
Decision Date 10/07/2011
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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