510(k) K181143

Keeler TonoCare Tonometer by Keeler Instruments, Inc. — Product Code HKX

K181143 is an FDA 510(k) premarket notification submitted by Keeler Instruments, Inc. for the device "Keeler TonoCare Tonometer". The FDA issued a decision of Substantially Equivalent on February 8, 2019. The device falls under product code HKX (Tonometer, Ac-Powered), a Class II device regulated under 21 CFR 886.1930. Keeler Instruments, Inc. has at least 10 other 510(k) clearances on record.