Panels › Cardiovascular › Product code JOQ · Class 2
Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only)
Regulation 870.1750
0510(k)s in 12 months (18 all time)
0recalls in 12 months (3 all time)
3recalls that name a 510(k)
Top companies in JOQ
| Company | 510(k)s | Recalls |
|---|---|---|
| Ep Medsystems | 3 | 1 |
| Medtronic Vascular | 4 | 0 |
| Micropace Pty, Ltd. | 2 | 0 |
| Cordis Corp. | 1 | 0 |
| Ep Medical, Inc. | 1 | 0 |
| Ep Technologies, Inc. | 1 | 0 |
| Fischer Imaging Corporation | 0 | 1 |
| Fischer Medical | 1 | 0 |
| Fischer Medical Technologies, Inc. | 1 | 0 |
| Heartware Intl. Corp. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 29, 2018 | K173439 | Bloom2 Programmable Electrophysiology Stimulator Fischer Medical | JOQ |
| Oct 16, 2009 | K092913 | EP-4TM CARDIAC STIMULATOR, MODELS: EP-04-02, EP-04-04 Ep Medsystems | JOQ |
| Oct 26, 2007 | K072200 | STIMLAB Micropace Pty, Ltd., AU | JOQ |
| Jul 2, 2007 | K070743 | Z6 STIMULATOR St Cardio Technologies, LLC | JOQ |
| Sep 14, 2004 | K041442 | EP-4 CLINICAL STIMUTATOR Ep Medsystems | JOQ |
| Feb 27, 2004 | K040207 | EP-4 CLINICAL STIMULATOR Ep Medsystems | JOQ |
| Jan 24, 2002 | K011826 | EPS320 CARDIAC STIMULATOR Micropace Pty, Ltd., AU | JOQ |
| May 5, 2000 | K991293 | EPSTIM ELECTROPHYSIOLOGY STIMULATOR CONTROL PROGRAM, BLOOM DTU-215 ELECTROPHYSIOLOGY PROGRAMMABLE STIMULATOR Fischer Medical Technologies, Inc. | JOQ |
| Nov 8, 1996 | K963579 | PACE-1A CARDIAC STIMULATOR Radionics, Inc. | JOQ |
| May 5, 1994 | K935590 | EP MEDICAL, INC. EP-3 CLINICAL STIMULATOR Ep Medical, Inc. | JOQ |
| Mar 13, 1990 | K900553 | CONSTANT CURRENT STIMULATOR MODEL 022101 Ep Technologies, Inc. | JOQ |
| Oct 2, 1989 | K893094 | HB 1000, BRUGADA ELECTROPHYSIOLOGY SYSTEM Heartware Intl. Corp. | JOQ |
| Aug 4, 1986 | K861368 | MEDTRONIC MODEL 5328 PROGRAMMABLE STIMULATOR Medtronic Vascular | JOQ |
| Sep 12, 1985 | K852746 | EXTERNAL PACEMAKER TELECTRONICS TE200 Seamed Corp. | JOQ |
| Jun 11, 1985 | K844815 | CORDIS ELECTROPHYSIOLOGY STIMULATOR Cordis Corp. | JOQ |
| Apr 16, 1985 | K851091 | MEDTRONIC MODEL 5328 PROGRAM-STIMULATOR Medtronic Vascular | JOQ |
| Sep 27, 1984 | K843718 | PROGRAMMABLE STIMULATOR 5326 Medtronic Vascular | JOQ |
| Jan 30, 1984 | K833421 | PROGRAMMABLE STIMULATOR 2352 Medtronic Vascular | JOQ |
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