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510(k) K101969

MH1 MICROHOLTER RECORDER by Exelys, LLC — Product Code MWJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 4, 2011
Date Received
July 13, 2010
Clearance Type
Traditional
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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