510(k) K152197

Skypro, SP01 Mask by Skypro Medical Supplies Company — Product Code FXX

K152197 is an FDA 510(k) premarket notification submitted by Skypro Medical Supplies Company for the device "Skypro, SP01 Mask". The FDA issued a decision of Substantially Equivalent on August 26, 2016. The device falls under product code FXX (Mask, Surgical), a Class II device regulated under 21 CFR 878.4040. Skypro Medical Supplies Company has at least 2 other 510(k) clearances on record.