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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 K895266
Device Name AMBULATORY (HOLTER) RECORDING SYSTEM - MODIFIED
Applicant
Biosensor Corp.
2700 Fwy. Blvd.
Minneapolis,  MN  55430
Applicant Contact STEVE SPRINGROSE
Correspondent
Biosensor Corp.
2700 Fwy. Blvd.
Minneapolis,  MN  55430
Correspondent Contact STEVE SPRINGROSE
Regulation Number870.1025
Classification Product Code
DSI  
Date Received08/23/1989
Decision Date 01/26/1990
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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