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FDA 510(k) Application Details - K030613
Device Classification Name
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
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510(K) Number
K030613
Device Name
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Applicant
CRITICARE SYSTEMS, INC.
20925 CROSSROADS CIRCLE
WAUKESHA, WI 53186 US
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Contact
ALEX KAPLAN
Other 510(k) Applications for this Contact
Regulation Number
870.1025
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Classification Product Code
MHX
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More FDA Info for this Product Code
Date Received
02/26/2003
Decision Date
04/17/2003
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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