510(k) K993434

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

K993434 is an FDA 510(k) premarket notification submitted by Biotronik, Inc. for the device "PIKOS 01, PIKOS E01, PIKOS 01-B, PIKOS E01-B, PIKOS 01-A, PIKOS E01-A". The FDA issued a decision of Substantially Equivalent on November 10, 1999. 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.