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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Computer, Diagnostic, Programmable
510(k) Number K950723
Device Name AMBULATORY (HOLTER) RECORDING SYSTEM
Applicant
Biosensor Corp.
13755 First Ave. N.
Minneapolis,  MN  55441
Applicant Contact DARREN D DERSHEM
Correspondent
Biosensor Corp.
13755 First Ave. N.
Minneapolis,  MN  55441
Correspondent Contact DARREN D DERSHEM
Regulation Number870.1425
Classification Product Code
DQK  
Date Received02/16/1995
Decision Date 02/09/1996
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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