510(k) K201896

ivi N3003 Surgical face Mask, ivi N6006 Surgical mask by Iob Medical, Inc. — Product Code FXX

K201896 is an FDA 510(k) premarket notification submitted by Iob Medical, Inc. for the device "ivi N3003 Surgical face Mask, ivi N6006 Surgical mask". The FDA issued a decision of Substantially Equivalent on March 30, 2021. The device falls under product code FXX (Mask, Surgical), a Class II device regulated under 21 CFR 878.4040. Iob Medical, Inc. has at least 6 other 510(k) clearances on record.