510(k) K173439 ยท JOQ Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only)
Bloom2 Programmable Electrophysiology Stimulator
| Applicant | Fischer Medical, Wheat Ridge CO, US |
| Decision | Substantially Equivalent, Mar 29, 2018 |
| Received | Nov 3, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K173439
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.