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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 K101969
Device Name MH1 MICROHOLTER RECORDER
Applicant
Exelys, LLC
1705 S. Capital Of Texas Hwy.,
Suite 500
Austin,  TX  78746
Applicant Contact NEAL KOLBER
Correspondent
Exelys, LLC
1705 S. Capital Of Texas Hwy.,
Suite 500
Austin,  TX  78746
Correspondent Contact NEAL KOLBER
Regulation Number870.2800
Classification Product Code
MWJ  
Date Received07/13/2010
Decision Date 02/04/2011
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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