510(k) K152561

Communicator Surgical Facemask with Clear Window by Prestige Ameritech , Ltd. — Product Code FXX

K152561 is an FDA 510(k) premarket notification submitted by Prestige Ameritech , Ltd. for the device "Communicator Surgical Facemask with Clear Window". The FDA issued a decision of Substantially Equivalent on June 3, 2016. The device falls under product code FXX (Mask, Surgical), a Class II device regulated under 21 CFR 878.4040. Prestige Ameritech , Ltd. has at least 5 other 510(k) clearances on record.