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510(k) K171360

CONTEC™ Electrocardiograph by Contec Medical Systems Co.,Ltd — Product Code DPS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 22, 2018
Date Received
May 9, 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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