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    K Number
    K993300
    Device Name
    COLDLIGHTSOURCE PL3000
    Manufacturer
    FIBER IMAGING TECHNOLOGIES, INC.
    Date Cleared
    1999-11-05

    (35 days)

    Product Code
    FCW, KOG
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    FIBER IMAGING TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Photonics Coldlightsource PL3000 is indicated for use to provide illumination through light-conducting devices such as fiberoptic cables.
    Device Description
    The Photonics Coldlightsource PL3000 is a lightsource for fiberoptic cables, with a 230/240 volt version which conforms to ENEC 11, EN60601, EN55011, and UL 2601. The 120 volt version is manufactured to the same requirements of these standards, and has been submitted for approval. Approval is anticipated in the immediate future.
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    K Number
    K992527
    Device Name
    URETERO-RENOSCOPE
    Manufacturer
    FIBER IMAGING TECHNOLOGIES, INC.
    Date Cleared
    1999-10-13

    (77 days)

    Product Code
    FGB
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    FIBER IMAGING TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Schoelly Uretero-Renoscopes are indicated for the transurethral examination and treatment of the upper urinmary tract, including the uterer and kidney, and, using additional accessories, to perform various diagnostic and therapeutic procedures.
    Device Description
    Schoelly Uretero-Renoscopes
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    K Number
    K992437
    Device Name
    SCHOELLY RIGID ENDOSCOPES
    Manufacturer
    FIBER IMAGING TECHNOLOGIES, INC.
    Date Cleared
    1999-09-14

    (54 days)

    Product Code
    GCJ
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    FIBER IMAGING TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Schoelly Laparoscope is indicated for examination of body cavities, holow organs, and canals, and using additional accessories, to perform various diagnostic and therapeutic procedures,
    Device Description
    Not Found
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    K Number
    K992040
    Device Name
    FLEXISCOPE II ARTHROSCOPES AND ACCESSORIES
    Manufacturer
    FIBER IMAGING TECHNOLOGIES, INC.
    Date Cleared
    1999-08-06

    (50 days)

    Product Code
    HRX
    Regulation Number
    888.1100
    Why did this record match?
    Applicant Name (Manufacturer) :

    FIBER IMAGING TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Schoelly Flexilux II Arthroscopes are indicated to permit a physician or surgeon to view the operative site during an arthroscopic procedure on the knee, shoulder, jaw, wrist, ankle, and elbow.
    Device Description
    Not Found
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    K Number
    K991560
    Device Name
    NASO-LARYNGO-PHARYNGOSCOPE
    Manufacturer
    FIBER IMAGING TECHNOLOGIES, INC.
    Date Cleared
    1999-07-13

    (70 days)

    Product Code
    EOB
    Regulation Number
    874.4760
    Why did this record match?
    Applicant Name (Manufacturer) :

    FIBER IMAGING TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Naso-Laryngo-Pharyngoscope is indicated for visualization of the pharynx and larynx.
    Device Description
    Not Found
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