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

    CAMERA, GAMMA

    K Number: K780060 · Decision Jan 26, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21
    Same Product Code
    129
    Applicant Total
    1
    Review Days
    15

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    Basic Information

    Device Name
    CAMERA, GAMMA
    K Number
    K780060
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    892.1100
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Ackerman-Schmehl Industries, Inc.
    Date Received
    January 11, 1978
    Decision Date
    January 26, 1978
    Product Code
    IYX
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

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

    Product Code Device Name
    IYX Camera, Scintillation (Gamma)

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