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

    RIWO DRIVE SYSTEM 2302 WITH GENERATOR, SMALL MOTOR HANDLES, 8563.111, 8563.351

    K Number: K984521 · Decision Mar 17, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36
    Same Product Code
    7
    Applicant Total
    142
    Review Days
    86

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    Basic Information

    Device Name
    RIWO DRIVE SYSTEM 2302 WITH GENERATOR, SMALL MOTOR HANDLES, 8563.111, 8563.351
    K Number
    K984521
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    874.4750
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Richard Wolf Medical Instruments Corp.
    Date Received
    December 21, 1998
    Decision Date
    March 17, 1999
    Product Code
    EQL
    Advisory Committee
    Ear, Nose, Throat
    Review Advisory Committee
    EN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    EQL Laryngostroboscope

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