510(k) K181260

MiiS Horus Scope DPT 100 by Medimaging Integrated Solution, Inc (Miis) — Product Code HKX

K181260 is an FDA 510(k) premarket notification submitted by Medimaging Integrated Solution, Inc (Miis) for the device "MiiS Horus Scope DPT 100". The FDA issued a decision of Substantially Equivalent on June 21, 2019. The device falls under product code HKX (Tonometer, Ac-Powered), a Class II device regulated under 21 CFR 886.1930. Medimaging Integrated Solution, Inc (Miis) has at least 6 other 510(k) clearances on record.