BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    EASIMIST ULTRASONIC NEBULIZER

    K Number: K921273 · Decision Apr 1, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    189
    Registration Numbers
    189
    Same Product Code
    507
    Applicant Total
    5
    Review Days
    745

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    Basic Information

    Device Name
    EASIMIST ULTRASONIC NEBULIZER
    K Number
    K921273
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5630
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Medix Corp.
    Date Received
    March 17, 1992
    Decision Date
    April 1, 1994
    Product Code
    CAF
    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
    CAF Nebulizer (Direct Patient Interface)

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    Other Clearances by Medix Corp.

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