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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Detector And Alarm, Arrhythmia
510(k) Number K922027
Device Name AMBULATORY (HOLTER) RECORDING, MODIFICATION
Applicant
Biosensor Corp.
6900 Wedgwood Rd., Suite 120
Minneapolis,  MN  55369
Applicant Contact STEVE SPRINGROSE
Correspondent
Biosensor Corp.
6900 Wedgwood Rd., Suite 120
Minneapolis,  MN  55369
Correspondent Contact STEVE SPRINGROSE
Regulation Number870.1025
Classification Product Code
DSI  
Date Received03/26/1992
Decision Date 02/17/1993
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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