510(k) K822268

NAGASHIMA NS-III ELECTRONYSTAGMOGRAPH by Kelleher Corp. — Product Code GWN

K822268 is an FDA 510(k) premarket notification submitted by Kelleher Corp. for the device "NAGASHIMA NS-III ELECTRONYSTAGMOGRAPH". The FDA issued a decision of Substantially Equivalent on January 28, 1983. The device falls under product code GWN (Nystagmograph), a Class II device regulated under 21 CFR 882.1460. Kelleher Corp. has at least 10 other 510(k) clearances on record.