FDA 510(k) Application Details - K001020

Device Classification Name Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)

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510(K) Number K001020
Device Name Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)
Applicant CRITICARE SYSTEMS, INC.
20925 CROSSROADS CIRCLE
WAUKESHA, WI 53186 US
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Contact ALEX KAPLAN
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Regulation Number 870.2300

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Classification Product Code MWI
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Date Received 03/30/2000
Decision Date 04/28/2000
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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