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

    EDI 320

    K Number: K873599 · Decision Oct 16, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    45
    Registration Numbers
    45
    Same Product Code
    32
    Applicant Total
    9
    Review Days
    42

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    Basic Information

    Device Name
    EDI 320
    K Number
    K873599
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    888.1500
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Applicant
    Cybex
    Date Received
    September 4, 1987
    Decision Date
    October 16, 1987
    Product Code
    KQX
    Advisory Committee
    Orthopedic
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KQX Goniometer, Ac-Powered

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