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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
510(k) Number K022435
Device Name 507EL VITAL SIGNS MONITOR
Applicant
Criticare Systems, Inc.
20925 Crossroads Cir.
Waukesha,  WI  53186
Applicant Contact ALEX KAPLAN
Correspondent
Criticare Systems, Inc.
20925 Crossroads Cir.
Waukesha,  WI  53186
Correspondent Contact ALEX KAPLAN
Regulation Number870.2300
Classification Product Code
DRT  
Date Received07/25/2002
Decision Date 08/14/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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