510(k) K141638

PROPPER INSIGHT BINOCULAR INDIRECT OPHTHALMOSOPE by Propper Manufacturing Co., Inc. — Product Code HLI

K141638 is an FDA 510(k) premarket notification submitted by Propper Manufacturing Co., Inc. for the device "PROPPER INSIGHT BINOCULAR INDIRECT OPHTHALMOSOPE". The FDA issued a decision of Substantially Equivalent on September 17, 2014. The device falls under product code HLI (Ophthalmoscope, Ac-Powered), a Class II device regulated under 21 CFR 886.1570. Propper Manufacturing Co., Inc. has at least 6 other 510(k) clearances on record.