BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    Wearable Device, Wearable Package

    K Number: K191272 · Decision Jul 12, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    72
    Registration Numbers
    72
    Same Product Code
    116
    Applicant Total
    4
    Review Days
    60

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    Basic Information

    Device Name
    Wearable Device, Wearable Package
    K Number
    K191272
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2300
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Current Health , Ltd.
    Date Received
    May 13, 2019
    Decision Date
    July 12, 2019
    Product Code
    MSX
    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
    MSX System, Network And Communication, Physiological Monitors

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    Other Clearances by Current Health , Ltd.

    K Number Device Name
    K231506 Current Health System
    K222550 Current Health System
    K190073 Wearable Device, Home Package in Carry Case with Homehub, Home Package in Carry Case without Homehub