FDA 510(k) Application Details - K014074

Device Classification Name Ventilator, Non-Continuous (Respirator)

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510(K) Number K014074
Device Name Ventilator, Non-Continuous (Respirator)
Applicant HOFFRICHTER GMBH
S65 W35739 PIPER RD.
EAGLE, WI 53119 US
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Contact STEPHEN H GORSKI
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Regulation Number 868.5905

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Classification Product Code BZD
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Date Received 12/10/2001
Decision Date 07/23/2003
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



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