510(k) K033130 ยท DTE Pulse-Generator, Pacemaker, External
PACE 101/PACE 101H, MODEL 3077 SSI TEMPORARY PULSE GENERATOR
| Applicant | Osypka Medical, Inc., La Jolla CA, US |
| Decision | Substantially Equivalent, Oct 31, 2003 |
| Received | Sep 30, 2003 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K033130
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.