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510(k) K151269

ECG Mini System Continuous ECG Monitor and Arrhythmia Detector by Lifewatch Technologies , Ltd. — Product Code DSI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 15, 2016
Date Received
May 13, 2015
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

Other clearances by Lifewatch Technologies , Ltd.

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  • K132407 — VITAL SIGNS PATCH SYSTEM (IN SHORT VSP) (December 19, 2014)

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