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

    TRANSESOPHAGEAL ULTRASOUND ACCESSORIES KIT

    K Number: K891180 · Decision Jun 15, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    1
    Applicant Total
    1
    Review Days
    101

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    Basic Information

    Device Name
    TRANSESOPHAGEAL ULTRASOUND ACCESSORIES KIT
    K Number
    K891180
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2890
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Ingress Technologies, Inc.
    Date Received
    March 6, 1989
    Decision Date
    June 15, 1989
    Product Code
    DXP
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DXP Transducer, Vessel Occlusion

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    UNICUFF

    FDA 510(k)
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