510(k) K151491

Falck Medical Multifunction Tonometer, FAT1 by Falck Medical, Inc. — Product Code HKY

K151491 is an FDA 510(k) premarket notification submitted by Falck Medical, Inc. for the device "Falck Medical Multifunction Tonometer, FAT1". The FDA issued a decision of Substantially Equivalent on January 15, 2016. The device falls under product code HKY (Tonometer, Manual), a Class II device regulated under 21 CFR 886.1930. Falck Medical, Inc. has at least 1 other 510(k) clearance on record.