510(k) K851745

1-100 UNIVERSAL SET OTOSCOPE & LARYNX EXPLORATON B by Artiberia — Product Code ERA

K851745 is an FDA 510(k) premarket notification submitted by Artiberia for the device "1-100 UNIVERSAL SET OTOSCOPE & LARYNX EXPLORATON B". The FDA issued a decision of Substantially Equivalent on August 29, 1985. The device falls under product code ERA (Otoscope), a Class I device regulated under 21 CFR 874.4770. Artiberia has at least 10 other 510(k) clearances on record.