Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only)
The Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only) is a cardiovascular device that delivers programmable electrical pulses to the heart via external means during electrophysiological studies, used to induce or terminate arrhythmias for diagnostic evaluation of the cardiac conduction system and arrhythmia mechanisms. This device is FDA Class 2, indicating moderate risk and requiring 510(k) premarket notification prior to marketing. It carries product code JOQ and is regulated under 21 CFR 870.1750, within the Cardiovascular medical specialty. This device is classified as life-sustaining or life-supporting.
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Basic Information
- Product Code
- JOQ
- Device Class
- FDA class 2
- Regulation Number
- 870.1750
- Medical Specialty
- Cardiovascular
- Review Panel
- CV
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 18 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K173439 | Bloom2 Programmable Electrophysiology Stimulator | Mar 29, 2018 | Substantially Equivalent | Fischer Medical |
| K092913 | EP-4TM CARDIAC STIMULATOR, MODELS: EP-04-02, EP-04-04 | Oct 16, 2009 | Substantially Equivalent | Ep Medsystems |
| K072200 | STIMLAB | Oct 26, 2007 | Substantially Equivalent | Micropace Pty, Ltd. |
| K070743 | Z6 STIMULATOR | Jul 02, 2007 | Substantially Equivalent | St Cardio Technologies, LLC |
| K041442 | EP-4 CLINICAL STIMUTATOR | Sep 14, 2004 | Substantially Equivalent | Ep Medsystems |
| K040207 | EP-4 CLINICAL STIMULATOR | Feb 27, 2004 | Substantially Equivalent | Ep Medsystems |
| K011826 | EPS320 CARDIAC STIMULATOR | Jan 24, 2002 | Substantially Equivalent | Micropace Pty, Ltd. |
| K991293 | EPSTIM ELECTROPHYSIOLOGY STIMULATOR CONTROL PROGRAM, BLOOM DTU-215 ELECTROPHYSIOLOGY PROGRAMMABLE STIMULATOR | May 05, 2000 | Substantially Equivalent | Fischer Medical Technologies, Inc. |
| K963579 | PACE-1A CARDIAC STIMULATOR | Nov 08, 1996 | Substantially Equivalent | Radionics, Inc. |
| K935590 | EP MEDICAL, INC. EP-3 CLINICAL STIMULATOR | May 05, 1994 | Substantially Equivalent | Ep Medical, Inc. |
| K900553 | CONSTANT CURRENT STIMULATOR MODEL 022101 | Mar 13, 1990 | Substantially Equivalent | Ep Technologies, Inc. |
| K893094 | HB 1000, BRUGADA ELECTROPHYSIOLOGY SYSTEM | Oct 02, 1989 | Substantially Equivalent | Heartware Intl. Corp. |
| K861368 | MEDTRONIC MODEL 5328 PROGRAMMABLE STIMULATOR | Aug 04, 1986 | Substantially Equivalent | Medtronic Vascular |
| K852746 | EXTERNAL PACEMAKER TELECTRONICS TE200 | Sep 12, 1985 | Substantially Equivalent | Seamed Corp. |
| K844815 | CORDIS ELECTROPHYSIOLOGY STIMULATOR | Jun 11, 1985 | Substantially Equivalent | Cordis Corp. |
| K851091 | MEDTRONIC MODEL 5328 PROGRAM-STIMULATOR | Apr 16, 1985 | Substantially Equivalent | Medtronic Vascular |
| K843718 | PROGRAMMABLE STIMULATOR 5326 | Sep 27, 1984 | Substantially Equivalent | Medtronic Vascular |
| K833421 | PROGRAMMABLE STIMULATOR 2352 | Jan 30, 1984 | Substantially Equivalent | Medtronic Vascular |
FEI Numbers
This FDA classification entry is associated with 6 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 6 registration numbers. Click on an entry to view related FDA registrations.