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

    SPEAKER-AMPLIFIER & RECORDER INTERFACE

    K Number: K780201 · Decision Mar 2, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    37
    Applicant Total
    2
    Review Days
    22

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    Basic Information

    Device Name
    SPEAKER-AMPLIFIER & RECORDER INTERFACE
    K Number
    K780201
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1540
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    L&M Ultrascope Life Monitoring Sys.
    Date Received
    February 8, 1978
    Decision Date
    March 2, 1978
    Product Code
    JAF
    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
    JAF Monitor, Ultrasonic, Nonfetal

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    Other Clearances by L&M Ultrascope Life Monitoring Sys.

    K Number Device Name
    K780200 ULTRASCOPE