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

    NEWTOM QR-DVT 9000

    K Number: K003787 · Decision Mar 8, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    46
    Registration Numbers
    46
    Same Product Code
    133
    Applicant Total
    2
    Review Days
    90

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    Basic Information

    Device Name
    NEWTOM QR-DVT 9000
    K Number
    K003787
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1750
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Aperio Services, LLC
    Date Received
    December 8, 2000
    Decision Date
    March 8, 2001
    Product Code
    OAS
    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
    OAS X-Ray, Tomography, Computed, Dental

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    Other Clearances by Aperio Services, LLC

    K Number Device Name
    K041137 NEWTOM 3G QR-DVT 9000