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

    FLEXIBLE ORTHOPEDIC ENDOSCOPE ICA-1000

    K Number: K841087 · Decision May 16, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    386
    Registration Numbers
    386
    Same Product Code
    680
    Applicant Total
    8
    Review Days
    64

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    Basic Information

    Device Name
    FLEXIBLE ORTHOPEDIC ENDOSCOPE ICA-1000
    K Number
    K841087
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.1100
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Applicant
    Machida America, Inc.
    Date Received
    March 13, 1984
    Decision Date
    May 16, 1984
    Product Code
    HRX
    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
    HRX Arthroscope

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