510(k) K951096

LIFESIGNS RECEIVING CENER 2000 TRANSTELEPHONIC RECEIVER by Instromedix, Inc. — Product Code DXH

K951096 is an FDA 510(k) premarket notification submitted by Instromedix, Inc. for the device "LIFESIGNS RECEIVING CENER 2000 TRANSTELEPHONIC RECEIVER". The FDA issued a decision of Substantially Equivalent on January 16, 1996. The device falls under product code DXH (Transmitters And Receivers, Electrocardiograph, Telephone), a Class II device regulated under 21 CFR 870.2920. Instromedix, Inc. has at least 10 other 510(k) clearances on record.