510(k) K982090

PACEART HOME TRAK PLUS EASI EVENT RECORDER SYSTEM by Paceart, Inc. — Product Code DXH

K982090 is an FDA 510(k) premarket notification submitted by Paceart, Inc. for the device "PACEART HOME TRAK PLUS EASI EVENT RECORDER SYSTEM". The FDA issued a decision of Substantially Equivalent on January 26, 1999. The device falls under product code DXH (Transmitters And Receivers, Electrocardiograph, Telephone), a Class II device regulated under 21 CFR 870.2920. Paceart, Inc. has at least 8 other 510(k) clearances on record.