JOQ — Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only) Class II
FDA product code JOQ covers "Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only)", a Class II medical device regulated under 21 CFR 870.1750. Submissions are reviewed by the Cardiovascular panel. At least 18 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- JOQ
- Device Class
- Class II
- Regulation Number
- 870.1750
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K173439 | fischer medical | Bloom2 Programmable Electrophysiology Stimulator | March 29, 2018 |
| K092913 | ep medsystems | EP-4TM CARDIAC STIMULATOR, MODELS: EP-04-02, EP-04-04 | October 16, 2009 |
| K072200 | micropace pty | STIMLAB | October 26, 2007 |
| K070743 | st cardio technologies | Z6 STIMULATOR | July 2, 2007 |
| K041442 | ep medsystems | EP-4 CLINICAL STIMUTATOR | September 14, 2004 |
| K040207 | ep medsystems | EP-4 CLINICAL STIMULATOR | February 27, 2004 |
| K011826 | micropace pty | EPS320 CARDIAC STIMULATOR | January 24, 2002 |
| K991293 | fischer medical technologies | EPSTIM ELECTROPHYSIOLOGY STIMULATOR CONTROL PROGRAM, BLOOM DTU-215 ELECTROPHYSIO | May 5, 2000 |
| K963579 | radionics | PACE-1A CARDIAC STIMULATOR | November 8, 1996 |
| K935590 | ep medical | EP MEDICAL, INC. EP-3 CLINICAL STIMULATOR | May 5, 1994 |
| K900553 | ep technologies | CONSTANT CURRENT STIMULATOR MODEL 022101 | March 13, 1990 |
| K893094 | heartware intl | HB 1000, BRUGADA ELECTROPHYSIOLOGY SYSTEM | October 2, 1989 |
| K861368 | medtronic vascular | MEDTRONIC MODEL 5328 PROGRAMMABLE STIMULATOR | August 4, 1986 |
| K852746 | seamed | EXTERNAL PACEMAKER TELECTRONICS TE200 | September 12, 1985 |
| K844815 | cordis | CORDIS ELECTROPHYSIOLOGY STIMULATOR | June 11, 1985 |
| K851091 | medtronic vascular | MEDTRONIC MODEL 5328 PROGRAM-STIMULATOR | April 16, 1985 |
| K843718 | medtronic vascular | PROGRAMMABLE STIMULATOR 5326 | September 27, 1984 |
| K833421 | medtronic vascular | PROGRAMMABLE STIMULATOR 2352 | January 30, 1984 |