510(k) K202255

Skypro, SP02 Mask (3) by Skypro Medical Supplies Company — Product Code FXX

K202255 is an FDA 510(k) premarket notification submitted by Skypro Medical Supplies Company for the device "Skypro, SP02 Mask (3)". The FDA issued a decision of Substantially Equivalent on Dec 24, 2021. 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.