BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    STANDEX

    K Number: K885343 · Decision May 1, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    248
    Registration Numbers
    248
    Same Product Code
    42
    Applicant Total
    1
    Review Days
    124

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    Basic Information

    Device Name
    STANDEX
    K Number
    K885343
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    890.5370
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Applicant
    Alt, Inc.
    Date Received
    December 28, 1988
    Decision Date
    May 1, 1989
    Product Code
    ION
    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
    ION Exerciser, Non-Measuring

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