FDA 510(k) Application Details - K110884

Device Classification Name Ventilator, Non-Continuous (Respirator)

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510(K) Number K110884
Device Name Ventilator, Non-Continuous (Respirator)
Applicant WEINMANN GERATE FUR MEDIZIN GMBH + CO. KG
KRONSAALSWEG 40
HAMBURG 22525 DE
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Contact RALF EGENOLF
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Regulation Number 868.5905

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Classification Product Code BZD
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Date Received 03/30/2011
Decision Date 07/12/2011
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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