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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 K243349
Device Name BodyGuardian Remote Monitoring System (BGRMS v3.0)
Applicant
Boston Scientific Cardiac Diagnostic Technologies, Inc.
2900 37th St. NW
Bldg. 003
Rochester,  MN  55901
Applicant Contact Meghan Styles
Correspondent
Boston Scientific Cardiac Diagnostic Technologies, Inc.
2900 37th St. NW
Bldg. 003
Rochester,  MN  55901
Correspondent Contact Meghan Styles
Regulation Number870.1025
Classification Product Code
DSI  
Subsequent Product Code
QYX  
Date Received10/28/2024
Decision Date 01/23/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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