510(k) K042003

INFINITY TRIDENT NMT POD by Draeger Medical Systems, Inc. — Product Code KOI

K042003 is an FDA 510(k) premarket notification submitted by Draeger Medical Systems, Inc. for the device "INFINITY TRIDENT NMT POD". The FDA issued a decision of Substantially Equivalent on September 1, 2004. The device falls under product code KOI (Stimulator, Nerve, Peripheral, Electric), a Class II device regulated under 21 CFR 868.2775. Draeger Medical Systems, Inc. has at least 10 other 510(k) clearances on record.