510(k) K911308

CARDIOTRACE-I TRANSTELEPHONIC ECG RECEIV CONSOLE by Medical Equipment Designs, Inc. — Product Code DXH

K911308 is an FDA 510(k) premarket notification submitted by Medical Equipment Designs, Inc. for the device "CARDIOTRACE-I TRANSTELEPHONIC ECG RECEIV CONSOLE". The FDA issued a decision of Substantially Equivalent on September 11, 1991. The device falls under product code DXH (Transmitters And Receivers, Electrocardiograph, Telephone), a Class II device regulated under 21 CFR 870.2920. Medical Equipment Designs, Inc. has at least 10 other 510(k) clearances on record.