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510(k) K170536

ECG Disposable Lead Wire by APK Technology Co., Ltd. — Product Code DSA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 24, 2017
Date Received
February 23, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cable, Transducer And Electrode, Patient, (Including Connector)
Device Class
Class II
Regulation Number
870.2900
Review Panel
CV
Submission Type

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