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

    MR SPECTROSCOPY PACKAGE

    K Number: K991568 · Decision Jul 19, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    50
    Registration Numbers
    50
    Same Product Code
    9
    Applicant Total
    190
    Review Days
    75

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    Basic Information

    Device Name
    MR SPECTROSCOPY PACKAGE
    K Number
    K991568
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1000
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Philips Medical Systems (Cleveland), Inc.
    Date Received
    May 5, 1999
    Decision Date
    July 19, 1999
    Product Code
    LNI
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LNI System, Nuclear Magnetic Resonance Spectroscopic

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