FDA 510(k) Application Details - K093925

Device Classification Name System,Network And Communication,Physiological Monitors

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510(K) Number K093925
Device Name System,Network And Communication,Physiological Monitors
Applicant PHYSIO-CONTROL, INC.
11811 WILLOWS ROAD NORTHEAST
P.O. BOX 97006
REDMOND, WA 98073-9706 US
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Contact TERESA DAVIDSON
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Regulation Number 870.2300

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Classification Product Code MSX
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Date Received 12/22/2009
Decision Date 01/12/2010
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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