FDA 510(k) Application Details - K090356

Device Classification Name Ventilator, Emergency, Powered (Resuscitator)

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510(K) Number K090356
Device Name Ventilator, Emergency, Powered (Resuscitator)
Applicant ALLIED HEALTHCARE PRODUCTS, INC.
1720 SUBLETTE AVE.
ST. LOUIS, MO 63110 US
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Contact WAYNE KARCHER
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Regulation Number 868.5925

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Classification Product Code BTL
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Date Received 02/12/2009
Decision Date 05/20/2009
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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