510(k) K043517

TRANSMITTER, ZS-940PA SERIES by Nihon Kohden America, Inc. — Product Code DRT

K043517 is an FDA 510(k) premarket notification submitted by Nihon Kohden America, Inc. for the device "TRANSMITTER, ZS-940PA SERIES". The FDA issued a decision of Substantially Equivalent on February 3, 2005. The device falls under product code DRT (Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)), a Class II device regulated under 21 CFR 870.2300. Nihon Kohden America, Inc. has at least 10 other 510(k) clearances on record.