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

    NEWMED ABP-LITE

    K Number: K955887 · Decision Sep 5, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    4
    Applicant Total
    2
    Review Days
    252

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    Basic Information

    Device Name
    NEWMED ABP-LITE
    K Number
    K955887
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1270
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Newmed Corp.
    Date Received
    December 28, 1995
    Decision Date
    September 5, 1996
    Product Code
    DXW
    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
    DXW System, Phonocatheter, Intracavitary

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