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

    CUDA PRODUCTS CORP. MODEL MX2-300 LIGHTSOURCE

    K Number: K934337 · Decision Nov 18, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    7
    Applicant Total
    17
    Review Days
    72

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    CUDA PRODUCTS CORP. MODEL MX2-300 LIGHTSOURCE
    K Number
    K934337
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4580
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Cuda Products Co.
    Date Received
    September 7, 1993
    Decision Date
    November 18, 1993
    Product Code
    FSW
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FSW Light, Surgical, Endoscopic

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (FSW), ordered by most recent decision date.

    RADLITE TISSUE RETRACTOR SYSTEM

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    XENALIGHT MODELS # AX9125 (100-120V~); # AX9225 (220-240V~)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    MEDICAM XENON LIGHT SOURCE

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    ILLUMINATOR IV MINOR SURGERY LIGHT

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    LM-300TWIN

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    MEDICAL DYNAMICS LIGHT SOURCE

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery
    View all

    Other Clearances by Cuda Products Co.

    K Number Device Name
    K983277 LIGHTSOURCE OR ILLUMINATOR MODEL I-100
    K981962 CUDA PRODUCTS CORP. MODEL M300 (M-300) LIGHTSOURCE
    K981469 CERMAX300 LIGHTSOURCE
    K980350 VIDEO CAMERA/LIGHTSOURCE COMBINATION UNIT MODEL VCL-150
    K980166 LIGHTSOURCE OR ILLUMINATOR
    K961074 LIGHTSOURCE OR ILLUMINATOR
    K951019 INTRAORAL VIDEO SCOPE AND WINDOW TUBE
    K943731 VIDEO OTOSCOPE
    K935818 ENDOSCOPE
    K933369 CUDA PRODUCTS CORP. LIGHTSOURCES
    Search all 17 clearances from Cuda Products Co. →