BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇱 Israel

    Vital Signs Patch System

    K Number: K151835 · Decision Feb 5, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    121
    Registration Numbers
    121
    Same Product Code
    397
    Applicant Total
    4
    Review Days
    214

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    Basic Information

    Device Name
    Vital Signs Patch System
    K Number
    K151835
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.1025
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Lifewatch Technologies , Ltd.
    Date Received
    July 6, 2015
    Decision Date
    February 5, 2016
    Product Code
    DSI
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DSI Detector And Alarm, Arrhythmia

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    Other Clearances by Lifewatch Technologies , Ltd.

    K Number Device Name
    K151269 ECG Mini System Continuous ECG Monitor and Arrhythmia Detector
    K143359 CG-6108 ACT-3L Continuous ECG Monitor and Arrhythmia Detector
    K132407 VITAL SIGNS PATCH SYSTEM (IN SHORT VSP)