510(k) K201137

Asept Surgical Face Mask by Pfm Medical, Inc. — Product Code FXX

K201137 is an FDA 510(k) premarket notification submitted by Pfm Medical, Inc. for the device "Asept Surgical Face Mask". The FDA issued a decision of Substantially Equivalent on August 19, 2020. The device falls under product code FXX (Mask, Surgical), a Class II device regulated under 21 CFR 878.4040. Pfm Medical, Inc. has at least 10 other 510(k) clearances on record.