510(k) K972631

ICS MEDICAL VEMR VIDEO EYE MOVEMENT RECORDER by Ics Medical Corp. — Product Code GWN

K972631 is an FDA 510(k) premarket notification submitted by Ics Medical Corp. for the device "ICS MEDICAL VEMR VIDEO EYE MOVEMENT RECORDER". The FDA issued a decision of Substantially Equivalent on September 22, 1997. The device falls under product code GWN (Nystagmograph), a Class II device regulated under 21 CFR 882.1460. Ics Medical Corp. has at least 10 other 510(k) clearances on record.