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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrocardiograph
510(k) Number K861067
Device Name PARAGON 420, 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 Number870.2340
Classification Product Code
DPS  
Date Received03/20/1986
Decision Date 06/05/1986
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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