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

    TCD 100M, PWD13 TRANSDUCER

    K Number: K002533 · Decision Aug 30, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    220
    Registration Numbers
    220
    Same Product Code
    1171
    Applicant Total
    2
    Review Days
    14

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    Basic Information

    Device Name
    TCD 100M, PWD13 TRANSDUCER
    K Number
    K002533
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1550
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Spencer Technologies
    Date Received
    August 16, 2000
    Decision Date
    August 30, 2000
    Product Code
    IYN
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    Y

    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 Spencer Technologies

    K Number Device Name
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