FDA 510(k) Application Details - K993307

Device Classification Name Ventilator, Non-Continuous (Respirator)

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510(K) Number K993307
Device Name Ventilator, Non-Continuous (Respirator)
Applicant RESPIRONICS, INC.
1001 MURRY RIDGE LN.
MURRYSVILLE, PA 15668 US
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Contact DAVID J VANELLA
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Regulation Number 868.5905

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Classification Product Code BZD
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Date Received 10/04/1999
Decision Date 10/27/1999
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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