510(k) K994011 ยท DQK Computer, Diagnostic, Programmable
EP MEDSYSTEMS, EP-WORKMATE
| Applicant | Ep Medsystems, Inc., Mount Arlington NJ, US |
| Decision | Substantially Equivalent, Mar 23, 2000 |
| Received | Nov 26, 1999 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K994011
| 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 |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.