510(k) K040207 ยท JOQ Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only)
EP-4 CLINICAL STIMULATOR
| Applicant | Ep Medsystems, West Berlin NJ, US |
| Decision | Substantially Equivalent, Feb 27, 2004 |
| Received | Jan 30, 2004 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K040207
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 12, 2009 | St. Jude Medical EP-4 Computerized Cardiac Stimulator; SJM Part Numbers: 09-1527-0000 / 09-1527-0002;
EP MedSystems, Inc.
575 Route 73 North, Units D, West Berlin, NJ 08091.
Indicated for use during clinical electrop Terminated |
JOQ | None listed |
| May 31, 2006 | EP Medsystems EP-4 Computerized Stimulator -- 2 channel and 4 channel. The product consists of a touchscreen portable PC controlling a two channel dedicated EP stimulator. The stimulator is capable of single chan Terminated |
JOQ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.