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

    MODEL UST-SSD 880L1-5 TRANESOPHAGEAL PHASED ARRAY

    K Number: K861710 · Decision Jul 9, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    77
    Applicant Total
    206
    Review Days
    65

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    Basic Information

    Device Name
    MODEL UST-SSD 880L1-5 TRANESOPHAGEAL PHASED ARRAY
    K Number
    K861710
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2330
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Johnson & Johnson Professionals, Inc.
    Date Received
    May 5, 1986
    Decision Date
    July 9, 1986
    Product Code
    DXK
    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
    DXK Echocardiograph

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