BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    ECO-RX AIR PURIFIER WITH UV LIGHT, MODEL RX-400

    K Number: K062716 · Decision Oct 27, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    16
    Registration Numbers
    16
    Same Product Code
    35
    Applicant Total
    1
    Review Days
    45

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    Basic Information

    Device Name
    ECO-RX AIR PURIFIER WITH UV LIGHT, MODEL RX-400
    K Number
    K062716
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.6500
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Eco-Rx, Inc.
    Date Received
    September 12, 2006
    Decision Date
    October 27, 2006
    Product Code
    FRA
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    Y

    Classifications

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

    Product Code Device Name
    FRA Purifier, Air, Ultraviolet, Medical

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