510(k) K963579

PACE-1A CARDIAC STIMULATOR by Radionics, Inc. — Product Code JOQ

K963579 is an FDA 510(k) premarket notification submitted by Radionics, Inc. for the device "PACE-1A CARDIAC STIMULATOR". The FDA issued a decision of Substantially Equivalent on November 8, 1996. The device falls under product code JOQ (Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only)), a Class II device regulated under 21 CFR 870.1750. Radionics, Inc. has at least 10 other 510(k) clearances on record.