510(k) K973064

KEELER TEARSCOPE-PLUS by Keeler Instruments, Inc. — Product Code HJO

K973064 is an FDA 510(k) premarket notification submitted by Keeler Instruments, Inc. for the device "KEELER TEARSCOPE-PLUS". The FDA issued a decision of Substantially Equivalent on April 7, 1998. The device falls under product code HJO (Biomicroscope, Slit-Lamp, Ac-Powered), a Class II device regulated under 21 CFR 886.1850. Keeler Instruments, Inc. has at least 10 other 510(k) clearances on record.