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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 K153473
Device Name Braemar Telemetry Patch System
Applicant
Braemar Manufacturing, LLC
3890 Murphy Canyon Rd.
Suite 100
San Diego,  CA  92123
Applicant Contact Kent Sayler
Correspondent
Braemar Manufacturing, LLC
3890 Murphy Canyon Rd.
Suite 100
San Diego,  CA  92123
Correspondent Contact Kent Sayler
Regulation Number870.1025
Classification Product Code
DSI  
Date Received12/02/2015
Decision Date 07/22/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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