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510(k) K131897

CV3000 HOLTER ANALYSIS SYSTEM by Vales & Hills Biomedical Tech. , Ltd. — Product Code MLO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 26, 2013
Date Received
June 25, 2013
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

Other clearances by Vales & Hills Biomedical Tech. , Ltd.

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