BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    accufit

    K Number: K233926 · Decision Mar 21, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    166
    Registration Numbers
    166
    Same Product Code
    543
    Applicant Total
    2
    Review Days
    99

    Basic Information

    Device Name
    accufit
    K Number
    K233926
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5850
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Mettler Electronics Corporation
    Date Received
    December 13, 2023
    Decision Date
    March 21, 2024
    Product Code
    IPF
    Advisory Committee
    Physical Medicine
    Review Advisory Committee
    PM
    Third Party
    N

    Classifications

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

    Product Code Device Name
    IPF Stimulator, Muscle, Powered

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    Other Clearances by Mettler Electronics Corporation

    K Number Device Name
    K223802 accufit