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

    NUCLEAR STETHOSCOPE

    K Number: K780510 · Decision Apr 18, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    2
    Applicant Total
    1
    Review Days
    19

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    Basic Information

    Device Name
    NUCLEAR STETHOSCOPE
    K Number
    K780510
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    892.1410
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Bios, Inc.
    Date Received
    March 30, 1978
    Decision Date
    April 18, 1978
    Product Code
    IYY
    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
    IYY Synchronizer, Electrocardiograph, Nuclear

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