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510(k) K063339

MEDICK MHM200 PERSONAL HEART MONITOR by Medick Healthcare , Ltd. — Product Code MLO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 29, 2007
Date Received
November 6, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrocardiograph, Ambulatory, With Analysis Algorithm
Device Class
Class II
Regulation Number
870.2800
Review Panel
CV
Submission Type

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