510(k) K122383 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
EM3 AEM MONITOR AEM CONNECTORS
| Applicant | Encision, Inc., Boulder CO, US |
| Decision | Substantially Equivalent, Jan 10, 2013 |
| Received | Aug 6, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K122383
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.