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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 K842435
Device Name MODEL T 101 CLINICAL TRANSMITTER
Applicant
Biometric Products, Inc.
4275a SW 73rd Ave.
Miami,  FL  33155
Applicant Contact LOUIS KATCHIS
Correspondent
Biometric Products, Inc.
4275a SW 73rd Ave.
Miami,  FL  33155
Correspondent Contact LOUIS KATCHIS
Regulation Number870.2920
Classification Product Code
DXH  
Date Received06/20/1984
Decision Date 05/16/1985
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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