510(k) K946043

H5000, H5000L, H5000L REVERSE MODEL H5000C, H5000CG by Rudolf Riester GmbH & Co. KG — Product Code ERA

K946043 is an FDA 510(k) premarket notification submitted by Rudolf Riester GmbH & Co. KG for the device "H5000, H5000L, H5000L REVERSE MODEL H5000C, H5000CG". The FDA issued a decision of Substantially Equivalent (kit) on March 8, 1995. The device falls under product code ERA (Otoscope), a Class I device regulated under 21 CFR 874.4770. Rudolf Riester GmbH & Co. KG has at least 10 other 510(k) clearances on record.