FDA 510(k) Application Details - K071163

Device Classification Name Ventilator, Non-Continuous (Respirator)

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510(K) Number K071163
Device Name Ventilator, Non-Continuous (Respirator)
Applicant WEINMANN GERATE FUR MEDIZIN GMBH + CO. KG
KRONSAALSWEG 40
HAMBURG 22525 DE
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Contact ECKHARDT ALBERS
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Regulation Number 868.5905

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Classification Product Code BZD
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Date Received 04/26/2007
Decision Date 07/18/2007
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review

FDA Source Information for K071163


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