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

    SKYNDEX ELECTRONIC BODY FAT CALCULA

    K Number: K841687 · Decision Jun 28, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    194
    Registration Numbers
    194
    Same Product Code
    6
    Applicant Total
    1
    Review Days
    66

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    Basic Information

    Device Name
    SKYNDEX ELECTRONIC BODY FAT CALCULA
    K Number
    K841687
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    888.4150
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Applicant
    Caldwell, Justiss & Co., Inc.
    Date Received
    April 23, 1984
    Decision Date
    June 28, 1984
    Product Code
    KTZ
    Advisory Committee
    Orthopedic
    Review Advisory Committee
    CH
    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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