510(k) K001634

CARDIOSENTRY EVENT MONITOR, MODEL 8470-01 by Tz Medical, Inc. — Product Code DXH

K001634 is an FDA 510(k) premarket notification submitted by Tz Medical, Inc. for the device "CARDIOSENTRY EVENT MONITOR, MODEL 8470-01". The FDA issued a decision of Substantially Equivalent on December 21, 2000. The device falls under product code DXH (Transmitters And Receivers, Electrocardiograph, Telephone), a Class II device regulated under 21 CFR 870.2920. Tz Medical, Inc. has at least 10 other 510(k) clearances on record.