SoClean Obtains FDA Clearance - 2024/08/20
Aug 20, 2024 · SoClean, a pioneer in bacterial reduction systems for CPAP hoses and masks, is pleased to announce it has been granted De Novo clearance by the FDA for the SoClean 3+.
DEN210037, SoClean 3+ Bacterial Reduction Device, SoClean, Inc.
The SoClean 3+ device is intended to be used as an adjunct to reduce bacterial populations on certain compatible home use CPAP mask and ventilation hoses after cleaning.
FDA Clears SoClean 3+ CPAP Bacterial Reduction Device
Aug 20, 2024 · SoClean 3+ is intended to be used as an adjunct to reduce bacterial populations on certain compatible home-use CPAP masks and ventilation hoses after cleaning. The FDA notes the …
SoClean 3+ obtains FDA clearance - aasm.org
Aug 20, 2024 · The SoClean 3+ is a single-patient home-use cleaning device for compatible CPAP masks and hoses designed to be used after recommended cleaning procedures. The device is …
FDA OKs SoClean’s Latest CPAP Mask & Hose Bacterial Reduction Device
Aug 20, 2024 · SoClean, a company pioneering bacterial reduction systems for CPAP hoses and masks, has been awarded U.S. Food and Drug Administration (FDA) de novo clearance for its SoClean 3+ …
SoClean: There is now a way to regulate performance
Sep 13, 2024 · Hand-washing removes organic material (like facial oil and residue), whereas the SoClean 3+ is intended to be used as an adjunct to achieve 99.9% bacterial reduction in CPAP …
FDA Clears SoClean 3+ CPAP Bacterial Reduction Device | Sleep Review
Aug 20, 2024 · Summary: The FDA has granted De Novo clearance to SoClean for its SoClean 3+ device, an over-the-counter bacterial reduction system intended for CPAP masks and hoses. The …
SoClean 3+ Bacterial Reduction Device by SoClean, Inc. | FDA 510 (k ...
SoClean 3+ is an ozone-generating device used as an adjunct for bacterial reduction of certain compatible continuous positive airway pressure (CPAP) mask and hoses after performing the …
FDA grants de novo clearance to bacterial reduction device for
Aug 26, 2024 · The FDA has granted de novo clearance to SoClean 3+, an over-the-counter bacterial reduction device for certain CPAP masks and hoses designed to be used after their recommended …
The SoClean 3+ device is intended to be used as an adjunct to reduce bacterial populations on certain compatible home use CPAP mask and ventilation hoses after cleaning.