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

    SECTORTAC

    K Number: K812606 · Decision Oct 13, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    220
    Registration Numbers
    220
    Same Product Code
    1171
    Applicant Total
    4
    Review Days
    28

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    Basic Information

    Device Name
    SECTORTAC
    K Number
    K812606
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1550
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Echo Laboratories, Inc.
    Date Received
    September 15, 1981
    Decision Date
    October 13, 1981
    Product Code
    IYN
    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
    IYN System, Imaging, Pulsed Doppler, Ultrasonic

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    Other Clearances by Echo Laboratories, Inc.

    K Number Device Name
    K812776 TRANSDUCER ANTISEPTIC TOWELETTE
    K781649 ULTRASONIC TRANSDUCERS
    K781631 ECHO-OIL