FDA 510(k) Application Details - K061870

Device Classification Name Conditioner, Signal, Physiological

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510(K) Number K061870
Device Name Conditioner, Signal, Physiological
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 882.1845

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Classification Product Code GWK
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Date Received 07/03/2006
Decision Date 08/31/2006
Decision SESE - SUBST EQUIV
Classification Advisory Committee NE - Neurology
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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