510(k) K802419

AO NON-CONTACT II TONOMETER by American Optical Corp. — Product Code HKX

K802419 is an FDA 510(k) premarket notification submitted by American Optical Corp. for the device "AO NON-CONTACT II TONOMETER". The FDA issued a decision of Substantially Equivalent on November 12, 1980. The device falls under product code HKX (Tonometer, Ac-Powered), a Class II device regulated under 21 CFR 886.1930. American Optical Corp. has at least 10 other 510(k) clearances on record.