510(k) K911721

KEELER PULSAIR NON CONTACT TONOMETER, MODIFICATION by Keeler Instruments, Inc. — Product Code HKX

K911721 is an FDA 510(k) premarket notification submitted by Keeler Instruments, Inc. for the device "KEELER PULSAIR NON CONTACT TONOMETER, MODIFICATION". The FDA issued a decision of Substantially Equivalent on June 25, 1991. 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.