510(k) K134036 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
WAVETRONIC 5000 DIGITAL HF SURGICAL UNIT
| Applicant | Loktal Medical Electronics Ind. Com. Ltda- Epp, Austin TX, US |
| Decision | Substantially Equivalent, Oct 8, 2015 |
| Received | Dec 31, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K134036
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.