510(k) K991293 ยท JOQ Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only)
EPSTIM ELECTROPHYSIOLOGY STIMULATOR CONTROL PROGRAM, BLOOM DTU-215 ELECTROPHYSIOLOGY PROGRAMMABLE STIMULATOR
| Applicant | Fischer Medical Technologies, Inc., Denver CO, US |
| Decision | Substantially Equivalent, May 5, 2000 |
| Received | Apr 15, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K991293
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 19, 2005 | Fischer Imaging Corporation Bloom DTU-215-B Programmable Stimulator Terminated |
JOQ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.