510(k) K121747

FACEFIT AND FACEFIT PORTED NON-INVASIVE VENTILATION MASKS by Intersurgical Incorporated — Product Code BZD

K121747 is an FDA 510(k) premarket notification submitted by Intersurgical Incorporated for the device "FACEFIT AND FACEFIT PORTED NON-INVASIVE VENTILATION MASKS". The FDA issued a decision of Substantially Equivalent on March 14, 2013. The device falls under product code BZD (Ventilator, Non-Continuous (Respirator)), a Class II device regulated under 21 CFR 868.5905. Intersurgical Incorporated has at least 2 other 510(k) clearances on record.