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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transmitters And Receivers, Electrocardiograph, Telephone
510(k) Number K820986
Device Name EKG MONITORS, VARIOUS MODELS
Applicant
Dart Medical Equipment
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Dart Medical Equipment
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number870.2920
Classification Product Code
DXH  
Date Received04/06/1982
Decision Date 04/29/1982
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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