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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 K892370
Device Name DIGITAL TRANSTELEPHONIC ECG MONITORING SYSTEM
Applicant
Bio-Focus, Inc.
Box 450
Awosting Rd.
Pine Bush,  NY  12566
Applicant Contact ELBAUM, PH.D.
Correspondent
Bio-Focus, Inc.
Box 450
Awosting Rd.
Pine Bush,  NY  12566
Correspondent Contact ELBAUM, PH.D.
Regulation Number870.2920
Classification Product Code
DXH  
Date Received04/06/1989
Decision Date 08/28/1989
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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