3B Medical Achieves FDA 510(k) Clearance for Three iVolve CPAP Masks

3B/BMC, a global supplier of sleep diagnostics and sleep therapy products, announces FDA 510(k) clearance on the iVolve family of CPAP interfaces. The mask line rounds out 3B/BMC’s CPAP mask offering with a new premium, ultra lightweight, comfortable line of interfaces.

The iVolve mask line has dual extra soft silicone lining for added comfort, and extremely quiet ventilation. The iVolve line of mask consists of the: iVolve N2 Mini-Nasal, iVolve Nasal and iVolve Full Face Mask. Market launch on the iVolve series of masks is scheduled for February 2014.

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