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510(k) K063339

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

K063339 is an FDA 510(k) premarket notification submitted by Medick Healthcare , Ltd. for the device "MEDICK MHM200 PERSONAL HEART MONITOR". The FDA issued a decision of Substantially Equivalent on June 29, 2007. The device falls under product code MLO (Electrocardiograph, Ambulatory, With Analysis Algorithm), a Class II device regulated under 21 CFR 870.2800.

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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FDA data resources