BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇯🇵 Japan

    Life Scope PT BSM-1700 Series Bedside Monitor

    K Number: K220976 · Decision Jul 21, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    53
    Registration Numbers
    53
    Same Product Code
    28
    Applicant Total
    19
    Review Days
    108

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    Basic Information

    Device Name
    Life Scope PT BSM-1700 Series Bedside Monitor
    K Number
    K220976
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    868.2775
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Nihon Kohden Corporation
    Date Received
    April 4, 2022
    Decision Date
    July 21, 2022
    Product Code
    KOI
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KOI Stimulator, Nerve, Peripheral, Electric

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