510(k) K952328

NANOS, PIKOS 01/E01, 01-A, E01-B, LP 01/LP E01 by Biotronik, Inc. — Product Code DXY

K952328 is an FDA 510(k) premarket notification submitted by Biotronik, Inc. for the device "NANOS, PIKOS 01/E01, 01-A, E01-B, LP 01/LP E01". The FDA issued a decision of ST on September 29, 1995. The device falls under product code DXY (Implantable Pacemaker Pulse-Generator), a Class III device regulated under 21 CFR 870.3610. Biotronik, Inc. has at least 10 other 510(k) clearances on record.