510(k) K921815

TOMEY PE-300 PORTABLE ERG by Tomey Corporation USA — Product Code HLT

K921815 is an FDA 510(k) premarket notification submitted by Tomey Corporation USA for the device "TOMEY PE-300 PORTABLE ERG". The FDA issued a decision of Substantially Equivalent on July 15, 1992. The device falls under product code HLT (Preamplifier, Ac-Powered, Ophthalmic), a Class II device regulated under 21 CFR 886.1640. Tomey Corporation USA has at least 8 other 510(k) clearances on record.