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

    INNERSENSE(TM) DISPOSABLE MICROTRANSDUCER

    K Number: K924737 · Decision Aug 23, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    64
    Registration Numbers
    64
    Same Product Code
    63
    Applicant Total
    25
    Review Days
    335

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    Basic Information

    Device Name
    INNERSENSE(TM) DISPOSABLE MICROTRANSDUCER
    K Number
    K924737
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2870
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Becton Dickinson Vascular Access, Inc.
    Date Received
    September 22, 1992
    Decision Date
    August 23, 1993
    Product Code
    DXO
    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
    DXO Transducer, Pressure, Catheter Tip

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