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510(k) K130294

BRAEMAR CARDIOKEY HOLTER RECORDER by Braemar Manufacturing, LLC — Product Code MWJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 16, 2013
Date Received
February 6, 2013
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrocardiograph, Ambulatory (Without Analysis)
Device Class
Class II
Regulation Number
870.2800
Review Panel
CV
Submission Type

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