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510(k) K140847

CARDIOSPY ECG HOLTER SYSTEMS by Labtech Kft. — Product Code MLO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 5, 2014
Date Received
April 3, 2014
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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