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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 K910852
Device Name 507 NON-INVASIVE VITAL SIGNS MONITOR
Applicant
Criticare Systems, Inc.
P.O. Box 26556
Milwaukee,  WI  53226
Applicant Contact DER RUHR
Correspondent
Criticare Systems, Inc.
P.O. Box 26556
Milwaukee,  WI  53226
Correspondent Contact DER RUHR
Regulation Number870.2300
Classification Product Code
DRT  
Date Received02/27/1991
Decision Date 07/30/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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