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

    PHILLY BOLT ADULT PROCEDURE KIT

    K Number: K823459 · Decision Dec 22, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15
    Same Product Code
    58
    Applicant Total
    6
    Review Days
    34

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    Basic Information

    Device Name
    PHILLY BOLT ADULT PROCEDURE KIT
    K Number
    K823459
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1460
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Applicant
    Philadelphia Medical Specialties
    Date Received
    November 18, 1982
    Decision Date
    December 22, 1982
    Product Code
    GWN
    Advisory Committee
    Neurology
    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
    GWN Nystagmograph

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