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

    VES 3001/2 DUAL OUTPUT VIDEO ILLUMINATOR

    K Number: K981821 · Decision Jul 29, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    38
    Registration Numbers
    38
    Same Product Code
    19
    Applicant Total
    10
    Review Days
    68

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    Basic Information

    Device Name
    VES 3001/2 DUAL OUTPUT VIDEO ILLUMINATOR
    K Number
    K981821
    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
    Angiolaz, Inc.
    Date Received
    May 22, 1998
    Decision Date
    July 29, 1998
    Product Code
    FSS
    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
    FSS Light, Surgical, Floor Standing

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    K981819 ANGIOLAZ VES-1CAM
    K981827 VES 0281-M COMPLETE VIDEO ENDOSCOPIC VIDEO SYSTEM
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