BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    ANGIOLAZ VES-1CAM

    K Number: K981819 · Decision Aug 4, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49
    Same Product Code
    22
    Applicant Total
    10
    Review Days
    74

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    Basic Information

    Device Name
    ANGIOLAZ VES-1CAM
    K Number
    K981819
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4160
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Angiolaz, Inc.
    Date Received
    May 22, 1998
    Decision Date
    August 4, 1998
    Product Code
    FWF
    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
    FWF Camera, Television, Endoscopic, Without Audio

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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
    K981821 VES 3001/2 DUAL OUTPUT VIDEO ILLUMINATOR
    K981827 VES 0281-M COMPLETE VIDEO ENDOSCOPIC VIDEO SYSTEM
    K933868 ANGIOLAZ VIDEO ENDOSCOPIC SYSTEM MODEL CAMLUM1 AND ACCESSORIES
    K913129 ANGIOLAZ ANGIOSCOPE CATHETER
    K902329 ULTRA-VU ANGIOSCOPE