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510(k) K143359

CG-6108 ACT-3L Continuous ECG Monitor and Arrhythmia Detector by Lifewatch Technologies , Ltd. — Product Code DSI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 11, 2015
Date Received
November 24, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Detector And Alarm, Arrhythmia
Device Class
Class II
Regulation Number
870.1025
Review Panel
CV
Submission Type

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