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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 K933021
Device Name MODEL T131 MEMORY TRANSMITTER
Applicant
Biometric Products, Inc.
6340 SW 69 Ave.
Miami,  FL  33143
Applicant Contact LOUIS KATCHIS
Correspondent
Biometric Products, Inc.
6340 SW 69 Ave.
Miami,  FL  33143
Correspondent Contact LOUIS KATCHIS
Regulation Number870.2920
Classification Product Code
DXH  
Date Received06/22/1993
Decision Date 06/06/1994
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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