FDA 510(k) Application Details - K950849

Device Classification Name Ventilator, Non-Continuous (Respirator)

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510(K) Number K950849
Device Name Ventilator, Non-Continuous (Respirator)
Applicant DEVILBISS HEALTH CARE, INC.
P.O. BOX 635
SOMERSET, PA 15501-0635 US
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Contact MARK D'ANGELO
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Regulation Number 868.5905

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Classification Product Code BZD
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Date Received 02/24/1995
Decision Date 02/08/1996
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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