Home Article FDA grants auth to SoClean device 

FDA grants auth to SoClean device 

FDA grants auth to SoClean device 

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By HME News Staff

Updated 8:29 AM CDT, Mon August 19, 2024

WASHINGTON – The U.S. Food and Drug Administration has granted a marketing authorization to SoClean for its SoClean 3+ bacterial reduction device for use with CPAP accessories (two hoses ResMed ClimateLine Air tubing and SlimLine tubing) and one mask (ResMed Mirage FX mask) for the ResMed AirSense 10 CPAP device. The SoClean 3+ does not replace the cleaning steps recommended by manufacturers of CPAP devices. To date, there are no FDA cleared or approved devices for cleaning, disinfecting or sanitizing CPAP devices. Source: FDA Roundup for Aug. 16, 2024. 

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