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

    ISOROBIC SKINFOLD CALIPER

    K Number: K810116 · Decision Feb 4, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    194
    Registration Numbers
    194
    Same Product Code
    6
    Applicant Total
    1
    Review Days
    20

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    Basic Information

    Device Name
    ISOROBIC SKINFOLD CALIPER
    K Number
    K810116
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    888.4150
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Applicant
    Fitness Motivation Institute of America
    Date Received
    January 15, 1981
    Decision Date
    February 4, 1981
    Product Code
    KTZ
    Advisory Committee
    Orthopedic
    Review Advisory Committee
    OR
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KTZ Caliper

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