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510(k) Data Aggregation

    K Number
    K062716
    Device Name
    ECO-RX AIR PURIFIER WITH UV LIGHT, MODEL RX-400
    Manufacturer
    ECO-RX, INC.
    Date Cleared
    2006-10-27

    (45 days)

    Product Code
    FRA
    Regulation Number
    880.6500
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    ECO-RX, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The ECO-Rx Air Purifier with UV Light, Model Rx-400 is a flow-through indoor air-purification system for the inactivation of indoor airborne bacteria.

    Device Description

    Not Found

    AI/ML Overview

    The provided document is a 510(k) clearance letter from the FDA for the ECO-Rx Air Purifier with UV Light Model Rx-400/ Eco-Rx Three-Lamp Ultra-Violet Air Treatment System. This letter confirms that the device is substantially equivalent to a legally marketed predicate device.

    The letter does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria.

    Therefore, I cannot provide the requested information. This type of FDA letter focuses on substantial equivalence to a predicate device, not on presenting detailed performance study data.

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