JOQ · Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only)
Cardiovascular · 21 CFR 870.1750 · Class 2
Overview
| Product Code | JOQ |
|---|---|
| Device Name | Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only) |
| Regulation | 21 CFR 870.1750 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
| Life-Sustaining | Yes |
Recent Cleared Devices (19 of 19)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K173439 | Bloom2 Programmable Electrophysiology Stimulator | Fischer Medical | Mar 29, 2018 | SESE |
| K092913 | EP-4TM CARDIAC STIMULATOR, MODELS: EP-04-02, EP-04-04 | Ep Medsystems | Oct 16, 2009 | SESE |
| K072200 | STIMLAB | Micropace Pty, Ltd. | Oct 26, 2007 | SESE |
| K070743 | Z6 STIMULATOR | St Cardio Technologies, LLC | Jul 2, 2007 | SESE |
| K041442 | EP-4 CLINICAL STIMUTATOR | Ep Medsystems | Sep 14, 2004 | SESE |
| K040207 | EP-4 CLINICAL STIMULATOR | Ep Medsystems | Feb 27, 2004 | SESE |
| K011826 | EPS320 CARDIAC STIMULATOR | Micropace Pty, Ltd. | Jan 24, 2002 | SESE |
| K991293 | EPSTIM ELECTROPHYSIOLOGY STIMULATOR CONTROL PROGRAM, BLOOM DTU-215 ELECTROPHYSIOLOGY PROGRAMMABLE STIMULATOR | Fischer Medical Technologies, Inc. | May 5, 2000 | SESE |
| K963579 | PACE-1A CARDIAC STIMULATOR | Radionics, Inc. | Nov 8, 1996 | SESE |
| K935590 | EP MEDICAL, INC. EP-3 CLINICAL STIMULATOR | Ep Medical, Inc. | May 5, 1994 | SESE |
| P920032 | MODEL 4553 DUAL CHAM. DDD TEMP.CARDIAC PACEMAKER | Pace Medical | Mar 10, 1994 | APPR |
| K900553 | CONSTANT CURRENT STIMULATOR MODEL 022101 | Ep Technologies, Inc. | Mar 13, 1990 | SESE |
| K893094 | HB 1000, BRUGADA ELECTROPHYSIOLOGY SYSTEM | Heartware Intl. Corp. | Oct 2, 1989 | SESE |
| K861368 | MEDTRONIC MODEL 5328 PROGRAMMABLE STIMULATOR | Medtronic Vascular | Aug 4, 1986 | SESE |
| K852746 | EXTERNAL PACEMAKER TELECTRONICS TE200 | Seamed Corp. | Sep 12, 1985 | SESE |
| K844815 | CORDIS ELECTROPHYSIOLOGY STIMULATOR | Cordis Corp. | Jun 11, 1985 | SESE |
| K851091 | MEDTRONIC MODEL 5328 PROGRAM-STIMULATOR | Medtronic Vascular | Apr 16, 1985 | SESE |
| K843718 | PROGRAMMABLE STIMULATOR 5326 | Medtronic Vascular | Sep 27, 1984 | SESE |
| K833421 | PROGRAMMABLE STIMULATOR 2352 | Medtronic Vascular | Jan 30, 1984 | SESE |
Top Applicants
- Medtronic Vascular — 4 clearances
- Ep Medsystems — 3 clearances
- Micropace Pty, Ltd. — 2 clearances
- Cordis Corp. — 1 clearance
- Ep Medical, Inc. — 1 clearance
