510(k) K182224

SafeAir Smoke Evacuator compact by Lina Medical Aps — Product Code FYD

K182224 is an FDA 510(k) premarket notification submitted by Lina Medical Aps for the device "SafeAir Smoke Evacuator compact". The FDA issued a decision of Substantially Equivalent on February 7, 2019. The device falls under product code FYD (Apparatus, Exhaust, Surgical), a Class II device regulated under 21 CFR 878.5070. Lina Medical Aps has at least 10 other 510(k) clearances on record.