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

    ANGIOLAZ VIDEO ENDOSCOPIC SYSTEM MODEL CAMLUM1 AND ACCESSORIES

    K Number: K933868 · Decision Nov 10, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    38
    Registration Numbers
    38
    Same Product Code
    46
    Applicant Total
    10
    Review Days
    96

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    Basic Information

    Device Name
    ANGIOLAZ VIDEO ENDOSCOPIC SYSTEM MODEL CAMLUM1 AND ACCESSORIES
    K Number
    K933868
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Angiolaz, Inc.
    Date Received
    August 6, 1993
    Decision Date
    November 10, 1993
    Product Code
    GCT
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    GCT Light Source, Endoscope, Xenon Arc

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    Other Clearances by Angiolaz, Inc.

    K Number Device Name
    K994362 HEADLAMP HL2000.
    K992447 50 W METAL HALIDE ILLUMINATOR, VES 0501.
    K982397 VES 3001-M COMPLETE VIDEO ENDOSCOPIC SYSTEM
    K982409 VES 1501-M
    K981819 ANGIOLAZ VES-1CAM
    K981821 VES 3001/2 DUAL OUTPUT VIDEO ILLUMINATOR
    K981827 VES 0281-M COMPLETE VIDEO ENDOSCOPIC VIDEO SYSTEM
    K913129 ANGIOLAZ ANGIOSCOPE CATHETER
    K902329 ULTRA-VU ANGIOSCOPE