FDA 510(k) Application Details - K031656

Device Classification Name Ventilator, Continuous, Non-Life-Supporting

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510(K) Number K031656
Device Name Ventilator, Continuous, Non-Life-Supporting
Applicant RESPIRONICS, INC.
1001 MURRY RIDGE LN.
MURRYSVILLE, PA 15668 US
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Contact ZITA A YURKO
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Regulation Number 868.5895

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Classification Product Code MNS
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Date Received 05/28/2003
Decision Date 07/30/2003
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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