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510(k) K152863

Portable ECG Monitor by Contec Medical Systems Co.,Ltd — Product Code DPS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 22, 2016
Date Received
September 30, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrocardiograph
Device Class
Class II
Regulation Number
870.2340
Review Panel
CV
Submission Type

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