510(k) K951184

OTI MODEL 78-60 by Oti Medical, LLC — Product Code HJO

K951184 is an FDA 510(k) premarket notification submitted by Oti Medical, LLC for the device "OTI MODEL 78-60". The FDA issued a decision of Substantially Equivalent on May 12, 1995. The device falls under product code HJO (Biomicroscope, Slit-Lamp, Ac-Powered), a Class II device regulated under 21 CFR 886.1850. Oti Medical, LLC has at least 1 other 510(k) clearance on record.