510(k) K152308

Sensor Medical Single Use Tonometer Prism by Sensor Medical Technology, LLC — Product Code HKY

K152308 is an FDA 510(k) premarket notification submitted by Sensor Medical Technology, LLC for the device "Sensor Medical Single Use Tonometer Prism". The FDA issued a decision of Substantially Equivalent on October 13, 2015. The device falls under product code HKY (Tonometer, Manual), a Class II device regulated under 21 CFR 886.1930. Sensor Medical Technology, LLC has at least 2 other 510(k) clearances on record.