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

    Myriad SPECTRA Light Source

    K Number: K232567 · Decision Mar 14, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    4
    Applicant Total
    9
    Review Days
    203

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    Basic Information

    Device Name
    Myriad SPECTRA Light Source
    K Number
    K232567
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.4950
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Nico Corporation
    Date Received
    August 24, 2023
    Decision Date
    March 14, 2024
    Product Code
    QFX
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    QFX Diagnostic Neurosurgical Microscope Filter

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    Other Clearances by Nico Corporation

    K Number Device Name
    K191599 NICO Myriad NOVUS
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    K162075 NICO TRIOwand
    K150378 NICO BrainPath & Accessories, NICO BrainPath, NICO Shepherd's Hook
    K150993 NICO TRIOwand
    K120691 BRAIN PORT