510(k) K182839 ยท DTE Pulse-Generator, Pacemaker, External
Lifetech Cardio Model 8301 Temporary Pacemaker
| Applicant | Shenzhen Lifetech Cardio Medical Electronics Co., Ltd., Shenzhen, CN |
| Decision | Substantially Equivalent, Feb 28, 2019 |
| Received | Oct 9, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K182839
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.