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

    NOVATOME, MODEL: SU101-50

    K Number: K072051 · Decision Oct 3, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    22
    Applicant Total
    8
    Review Days
    69

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    Basic Information

    Device Name
    NOVATOME, MODEL: SU101-50
    K Number
    K072051
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4075
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Scholten Surgical Instruments, Inc.
    Date Received
    July 26, 2007
    Decision Date
    October 3, 2007
    Product Code
    DWZ
    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
    DWZ Device, Biopsy, Endomyocardial

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