FDA 510(k) Application Details - K013738

Device Classification Name Ventilator, Non-Continuous (Respirator)

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510(K) Number K013738
Device Name Ventilator, Non-Continuous (Respirator)
Applicant GOTTLIEB WEINMANN GERAETE FUER MEDIZIN UND ARBEITS
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 11/13/2001
Decision Date 01/22/2002
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 K013738


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