510(k) K193007

LiNA OperaScope with HDMI cable and on-board LCD - 6 units, LiNA OperaScope Recording Module by Lina Medical Aps — Product Code HIH

K193007 is an FDA 510(k) premarket notification submitted by Lina Medical Aps for the device "LiNA OperaScope with HDMI cable and on-board LCD - 6 units, LiNA OperaScope Recording Module". The FDA issued a decision of Substantially Equivalent on January 17, 2020. The device falls under product code HIH (Hysteroscope (And Accessories)), a Class II device regulated under 21 CFR 884.1690. Lina Medical Aps has at least 10 other 510(k) clearances on record.