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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name monitor, physiological, patient (without arrhythmia detection or alarms)
510(k) Number K042569
Device Name 8600 VITAL SIGNS MONITOR
Applicant
CRITICARE SYSTEMS, INC.
20925 CROSSROADS CIRCLE
WAUKESHA,  WI  53186
Applicant Contact ALEX KAPLAN
Correspondent
CRITICARE SYSTEMS, INC.
20925 CROSSROADS CIRCLE
WAUKESHA,  WI  53186
Correspondent Contact ALEX KAPLAN
Regulation Number870.2300
Classification Product Code
MWI  
Date Received09/21/2004
Decision Date 09/29/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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