510(k) K061780

TELEPHONE ELECTROCARDIOGRAPH TRANSMITTER AND RECEIVER, TTM FOR WINDOWS + by Rozinn Electronics, Inc. — Product Code DXH

K061780 is an FDA 510(k) premarket notification submitted by Rozinn Electronics, Inc. for the device "TELEPHONE ELECTROCARDIOGRAPH TRANSMITTER AND RECEIVER, TTM FOR WINDOWS +". The FDA issued a decision of Substantially Equivalent on September 15, 2006. The device falls under product code DXH (Transmitters And Receivers, Electrocardiograph, Telephone), a Class II device regulated under 21 CFR 870.2920. Rozinn Electronics, Inc. has at least 5 other 510(k) clearances on record.