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

    OPHTHALMIC FLUID DISTRIBUTION SETS

    K Number: K923972 · Decision Nov 4, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    66
    Registration Numbers
    66
    Same Product Code
    63
    Applicant Total
    49
    Review Days
    89

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    Basic Information

    Device Name
    OPHTHALMIC FLUID DISTRIBUTION SETS
    K Number
    K923972
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5440
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Visitec Co.
    Date Received
    August 7, 1992
    Decision Date
    November 4, 1992
    Product Code
    FPK
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FPK Tubing, Fluid Delivery

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