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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Echocardiograph
510(k) Number K903710
Device Name WASHINGTON CARDIAC MONITOR
Applicant
Washington Biolab, Inc.
P.O. Box 1182
Ames,  IA  50010
Applicant Contact KI, PH.D.
Correspondent
Washington Biolab, Inc.
P.O. Box 1182
Ames,  IA  50010
Correspondent Contact KI, PH.D.
Regulation Number870.2330
Classification Product Code
DXK  
Date Received08/14/1990
Decision Date 11/09/1990
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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