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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 K884524
Device Name HTS 220 CARDIAC MONITOR
Applicant
Life Sensing Instrument Company, Inc.
329 W. Lincoln St.
Tullahoma,  TN  37388
Applicant Contact B. Q CUTSHAW
Correspondent
Life Sensing Instrument Company, Inc.
329 W. Lincoln St.
Tullahoma,  TN  37388
Correspondent Contact B. Q CUTSHAW
Regulation Number870.1025
Classification Product Code
DSI  
Date Received10/27/1988
Decision Date 04/10/1989
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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