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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 K974546
Device Name BIOSENSOR HOLTER MONITOR SYSTEM
Applicant
Biosensor Corp.
7001 E. Fish Lake Rd.
Maple Grove,  MN  55311
Applicant Contact STEVE SPRINGROSE
Correspondent
Biosensor Corp.
7001 E. Fish Lake Rd.
Maple Grove,  MN  55311
Correspondent Contact STEVE SPRINGROSE
Regulation Number870.1425
Classification Product Code
DQK  
Date Received12/04/1997
Decision Date 03/04/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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