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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
HO
Reference & Predicate Devices
N/A
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.

§ 880.6500 Medical ultraviolet air purifier.

(a)
Identification. A medical ultraviolet air purifier is a device intended for medical purposes that is used to destroy bacteria in the air by exposure to ultraviolet radiation.(b)
Classification. Class II (performance standards).