510(k) K912379

PDT CARRYALL TRANSMITTER, VARIOUS MODELS by Cardiac Pacemakers, Inc. — Product Code DXH

K912379 is an FDA 510(k) premarket notification submitted by Cardiac Pacemakers, Inc. for the device "PDT CARRYALL TRANSMITTER, VARIOUS MODELS". The FDA issued a decision of Substantially Equivalent on June 17, 1991. The device falls under product code DXH (Transmitters And Receivers, Electrocardiograph, Telephone), a Class II device regulated under 21 CFR 870.2920. Cardiac Pacemakers, Inc. has at least 10 other 510(k) clearances on record.