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

    GETINGE/CASTLE OPTIVIEW SERIES SURGICAL LIGHT

    K Number: K974084 · Decision Mar 3, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    68
    Registration Numbers
    68
    Same Product Code
    73
    Applicant Total
    9
    Review Days
    125

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    Basic Information

    Device Name
    GETINGE/CASTLE OPTIVIEW SERIES SURGICAL LIGHT
    K Number
    K974084
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4580
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Getinge/Castle, Inc.
    Date Received
    October 29, 1997
    Decision Date
    March 3, 1998
    Product Code
    FSY
    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
    FSY Light, Surgical, Ceiling Mounted

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    Other Clearances by Getinge/Castle, Inc.

    K Number Device Name
    K020205 CASTLE PERACETIC ACID BIOLOGICAL INDICATOR KIT
    K020590 MODEL 733HC GRAVITY/VACUUM STEAM STERILIZER
    K012573 CASTLE 400HC/500HC SERIES STEAM STERILIZER, MODELS 422HC, 433HC, 522HC, AND 533HC
    K003441 CASTLE MODEL 233HC STEAM STERILIZER
    K994314 CASTLE SERIES 100HC STEAM STERILIZERS
    K993242 CASTLE SURGICAL LIGHT, MODEL 3000
    K973225 CASTLE SERIES 200 STEAM STERILIZER (POWERCLAVE)
    K970907 CASTLE SERIES 100 STEAM STERILIZERS (STRAIGHTLINE)