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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 K822616
Device Name LS6 ARRYTHMIA DISCRIMINATOR
Applicant
Life Science Instrumentation, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Life Science Instrumentation, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number870.1025
Classification Product Code
DSI  
Date Received08/30/1982
Decision Date 10/18/1982
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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