FDA 510(k) Application Details - K973106

Device Classification Name Ventilator, Emergency, Manual (Resuscitator)

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510(K) Number K973106
Device Name Ventilator, Emergency, Manual (Resuscitator)
Applicant ALLIED HEALTHCARE PRODUCTS, INC.
1720 SUBLETTE AVE.
ST. LOUIS, MO 63110 US
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Contact VERNON TRIMBLE
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Regulation Number 868.5915

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Classification Product Code BTM
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Date Received 08/19/1997
Decision Date 01/29/1998
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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