510(k) K890547

SIEMENS ELEMA MODELS 4025 AND 4026 ADAPTERS by Pacesetter Systems — Product Code DTB

K890547 is an FDA 510(k) premarket notification submitted by Pacesetter Systems for the device "SIEMENS ELEMA MODELS 4025 AND 4026 ADAPTERS". The FDA issued a decision of Substantially Equivalent on March 22, 1989. The device falls under product code DTB (Permanent Pacemaker Electrode), a Class III device regulated under 21 CFR 870.3680. Pacesetter Systems has at least 10 other 510(k) clearances on record.