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

    Current Health System

    K Number: K231506 · Decision Aug 24, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    72
    Registration Numbers
    72
    Same Product Code
    116
    Applicant Total
    4
    Review Days
    92

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    Basic Information

    Device Name
    Current Health System
    K Number
    K231506
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.2300
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Current Health , Ltd.
    Date Received
    May 24, 2023
    Decision Date
    August 24, 2023
    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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