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

    EZ SPRAY

    K Number: K972397 · Decision Sep 23, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    140
    Registration Numbers
    140
    Same Product Code
    61
    Applicant Total
    1
    Review Days
    89

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    Basic Information

    Device Name
    EZ SPRAY
    K Number
    K972397
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    868.5640
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Intertex Research, Inc.
    Date Received
    June 26, 1997
    Decision Date
    September 23, 1997
    Product Code
    CCQ
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    CCQ Nebulizer, Medicinal, Non-Ventilatory (Atomizer)

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