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FDA 510(k) Application Details - K022435
Device Classification Name
Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
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510(K) Number
K022435
Device Name
Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
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
DRT
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More FDA Info for this Product Code
Date Received
07/25/2002
Decision Date
08/14/2002
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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