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510(k) Data Aggregation

    K Number
    K983277
    Device Name
    LIGHTSOURCE OR ILLUMINATOR MODEL I-100
    Manufacturer
    CUDA PRODUCTS CO.
    Date Cleared
    1998-12-16

    (90 days)

    Product Code
    HBI, FCR, FCW, FFS, HET
    Regulation Number
    878.4580
    Why did this record match?
    Applicant Name (Manufacturer) :

    CUDA PRODUCTS CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To provide light for fiberoptic cables and instruments. Provide light for instrumentation via fiberoptic cables for use in surgical fields. For example: lightsource attaches to fiberoptic cable which is then attached to a headlight or microscope or video camera. The lightsource supplies light for the headlight or microscope or video camera.
    Device Description
    Lightsource or illuminator I-100
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    K Number
    K981962
    Device Name
    CUDA PRODUCTS CORP. MODEL M300 (M-300) LIGHTSOURCE
    Manufacturer
    CUDA PRODUCTS CO.
    Date Cleared
    1998-08-18

    (75 days)

    Product Code
    FSS
    Regulation Number
    878.4580
    Why did this record match?
    Applicant Name (Manufacturer) :

    CUDA PRODUCTS CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To provide light for fiberoptic cables and instruments. Provide light for instrumentation via fiberoptic cables for use in surgical fields. For example: lightsource attaches to fiberoptic cable which is then attached to a headlight or Endoscope. The lightsource supplies light for the headlight or Endoscope.
    Device Description
    Lightsource or illuminator M-300
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    K Number
    K981469
    Device Name
    CERMAX300 LIGHTSOURCE
    Manufacturer
    CUDA PRODUCTS CO.
    Date Cleared
    1998-07-09

    (77 days)

    Product Code
    FSS
    Regulation Number
    878.4580
    Why did this record match?
    Applicant Name (Manufacturer) :

    CUDA PRODUCTS CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To provide light for fiberoptic cables and instruments. Provide light for instrumentation via fiberoptic cables for use in surgical fields. For example: Ilightsource attaches to fiberoptic cable which is then attached to a headlight or Endoscope. The lightsource supplies light for the headlight or Endoscope.
    Device Description
    Lightsource or illuminator CERMAX300
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    K Number
    K980350
    Device Name
    VIDEO CAMERA/LIGHTSOURCE COMBINATION UNIT MODEL VCL-150
    Manufacturer
    CUDA PRODUCTS CO.
    Date Cleared
    1998-04-28

    (90 days)

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

    CUDA PRODUCTS CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To provide light for fiberoptic cables and provide a camera for procedure video capabilities. Provide light for instrumentation via fiberoptic cables For for use in. surgical fields or in office procedures. lightsource attaches to fiberoptic cable which is then attached to a video scope, the camera also attaches to the video scope (such as a video otoscope, or an intra oral dental scope).
    Device Description
    Video Camera/Lightsource Combination Unit VCL-150
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    K Number
    K980166
    Device Name
    LIGHTSOURCE OR ILLUMINATOR
    Manufacturer
    CUDA PRODUCTS CO.
    Date Cleared
    1998-04-01

    (75 days)

    Product Code
    HET, FCR, FCW, FFS, HBI
    Regulation Number
    884.1720
    Why did this record match?
    Applicant Name (Manufacturer) :

    CUDA PRODUCTS CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To provide light for fiberoptic cables and instruments. Provide light for instrumentation via fiberoptic cables for use in surgical fields. For example: lightsource actaches to fiberoptic cable which is then attached to an instrument or headlight.
    Device Description
    Lightsource or Illuminator M2-250TR or 1-250
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    K Number
    K961074
    Device Name
    LIGHTSOURCE OR ILLUMINATOR
    Manufacturer
    CUDA PRODUCTS CO.
    Date Cleared
    1996-04-30

    (43 days)

    Product Code
    FSS
    Regulation Number
    878.4580
    Why did this record match?
    Applicant Name (Manufacturer) :

    CUDA PRODUCTS CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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