510(k) K152644

KEELER DISPOSABLE TONOMATE, KEELER DISPOSABLE TONOMATE, BOX OF 100 by Keeler Limited — Product Code HKY

K152644 is an FDA 510(k) premarket notification submitted by Keeler Limited for the device "KEELER DISPOSABLE TONOMATE, KEELER DISPOSABLE TONOMATE, BOX OF 100". The FDA issued a decision of Substantially Equivalent on December 31, 2015. The device falls under product code HKY (Tonometer, Manual), a Class II device regulated under 21 CFR 886.1930. Keeler Limited has at least 4 other 510(k) clearances on record.