Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only)
FDA product code JOQ · Class II (moderate risk) · 21 CFR 870.1750 · Cardiovascular
18510(k) clearances
1PMA approvals
1recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K173439 | Bloom2 Programmable Electrophysiology StimulatorJOQ · Traditional | Fischer Medical | 03/29/2018SE |
| K092913 | EP-4TM Cardiac Stimulator, Models: EP-04-02, EP-04-04JOQ · Special | Ep Medsystems | 10/16/2009SE |
| K072200 | StimlabJOQ · Traditional | Micropace Pty, Ltd. | 10/26/2007SE |
| K070743 | Z6 StimulatorJOQ · Traditional | St Cardio Technologies, LLC | 07/02/2007SE |
| K041442 | EP-4 Clinical StimutatorJOQ · Special | Ep Medsystems | 09/14/2004SE |
| K040207 | EP-4 Clinical StimulatorJOQ · Special | Ep Medsystems | 02/27/2004SE |
| K011826 | EPS320 Cardiac StimulatorJOQ · Traditional | Micropace Pty, Ltd. | 01/24/2002SE |
| K991293 | Epstim Electrophysiology Stimulator Control Program, Bloom DTU-215 Electrophysiology…JOQ · Traditional | Fischer Medical Technologies, Inc. | 05/05/2000SE |
| K963579 | PACE-1A Cardiac StimulatorJOQ · Traditional | Radionics, Inc. | 11/08/1996SE |
| K935590 | Ep Medical, Inc. EP-3 Clinical StimulatorJOQ · Traditional | Ep Medical, Inc. | 05/05/1994SE |
| K900553 | Constant Current Stimulator Model 022101JOQ · Traditional | Ep Technologies, Inc. | 03/13/1990SE |
| K893094 | HB 1000, Brugada Electrophysiology SystemJOQ · Traditional | Heartware Intl. Corp. | 10/02/1989SE |
| K861368 | Medtronic Model 5328 Programmable StimulatorJOQ · Traditional | Medtronic Vascular | 08/04/1986SE |
| K852746 | External Pacemaker Telectronics TE200JOQ · Traditional | Seamed Corp. | 09/12/1985SE |
| K844815 | Cordis Electrophysiology StimulatorJOQ · Traditional | Cordis Corp. | 06/11/1985SE |
| K851091 | Medtronic Model 5328 Program-StimulatorJOQ · Traditional | Medtronic Vascular | 04/16/1985SE |
| K843718 | Programmable Stimulator 5326JOQ · Traditional | Medtronic Vascular | 09/27/1984SE |
| K833421 | Programmable Stimulator 2352JOQ · Traditional | Medtronic Vascular | 01/30/1984SE |
PMA approvals
- P920032 Model 4553 Dual Cham. DDD Temp.Cardiac Pacemaker · Pace Medical · 03/10/1994
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1422-2009 | EP-4 Computerized Cardiac Stimulator; SJM Part Numbers: 09-1527-0000 / 09-1527-0002; EP…Non-compliance with IEC Standard 60601-1 Clause 57.6 relative to fusing of AC input line. The neutral line… | St. Jude Medical | 03/23/2009Terminated |