510(k) K992598

TOF-WATCH SX by Organon Teknika Corp. — Product Code KOI

K992598 is an FDA 510(k) premarket notification submitted by Organon Teknika Corp. for the device "TOF-WATCH SX". The FDA issued a decision of Substantially Equivalent on August 30, 1999. The device falls under product code KOI (Stimulator, Nerve, Peripheral, Electric), a Class II device regulated under 21 CFR 868.2775. Organon Teknika Corp. has at least 10 other 510(k) clearances on record.