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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name outpatient cardiac telemetry
510(k) Number K170565
Device Name LifeWatch Mobile Cardiac Telemetry 3 Lead LifeWatch MCT 3L
Applicant
LifeWatch Services, Inc
10255 W Higgins Road
Suite 100
Rosemont,  IL  60018
Applicant Contact Stefanie Martinez-Koenig
Correspondent
LifeWatch Services, Inc
10255 W Higgins Road
Suite 100
Rosemont,  IL  60018
Correspondent Contact Stefanie Martinez-Koenig
Regulation Number870.1025
Classification Product Code
QYX  
Subsequent Product Code
DSI  
Date Received02/27/2017
Decision Date 08/01/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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