510(k) K201380

Livocare Surgical Mask by Andon Health Co, Ltd. — Product Code FXX

K201380 is an FDA 510(k) premarket notification submitted by Andon Health Co, Ltd. for the device "Livocare Surgical Mask". The FDA issued a decision of Substantially Equivalent on October 7, 2020. The device falls under product code FXX (Mask, Surgical), a Class II device regulated under 21 CFR 878.4040. Andon Health Co, Ltd. has at least 10 other 510(k) clearances on record.