510(k) K212366

Heartland Health Surgical Mask by Heartland Health Products — Product Code FXX

K212366 is an FDA 510(k) premarket notification submitted by Heartland Health Products for the device "Heartland Health Surgical Mask". The FDA issued a decision of Substantially Equivalent on Feb 19, 2022. The device falls under product code FXX (Mask, Surgical), a Class II device regulated under 21 CFR 878.4040.