FDA 510(k) Application Details - K953930

Device Classification Name Ventilator, Non-Continuous (Respirator)

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510(K) Number K953930
Device Name Ventilator, Non-Continuous (Respirator)
Applicant RESPIRONICS, INC.
1001 MURRY RIDGE LN.
MURRYSVILLE, PA 15668 US
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Contact RICHARD G CONFER
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Regulation Number 868.5905

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Classification Product Code BZD
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Date Received 08/21/1995
Decision Date 09/30/1996
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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