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510(k) K170954

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 30, 2017
Date Received
March 31, 2017
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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