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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrocardiograph, Ambulatory (Without Analysis)
510(k) Number K130294
Device Name BRAEMAR CARDIOKEY HOLTER RECORDER
Applicant
BRAEMAR MANUFACTURING LLC
750 B. STREET, STUITE 1400
SAN DIEGO,  CA  92101
Applicant Contact KENT SAYLER
Correspondent
BRAEMAR MANUFACTURING LLC
750 B. STREET, STUITE 1400
SAN DIEGO,  CA  92101
Correspondent Contact KENT SAYLER
Regulation Number870.2800
Classification Product Code
MWJ  
Date Received02/06/2013
Decision Date 10/16/2013
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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