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

    MOISTAIR FLUID AIR TUBING SET

    K Number: K974561 · Decision Feb 19, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    81
    Registration Numbers
    81
    Same Product Code
    39
    Applicant Total
    6
    Review Days
    76

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    Basic Information

    Device Name
    MOISTAIR FLUID AIR TUBING SET
    K Number
    K974561
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.4360
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    American Medical Devices, Inc.
    Date Received
    December 5, 1997
    Decision Date
    February 19, 1998
    Product Code
    KYG
    Advisory Committee
    Ophthalmic
    Review Advisory Committee
    OP
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KYG Device, Irrigation, Ocular Surgery

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    Other Clearances by American Medical Devices, Inc.

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