510(k) K093622 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
AEM MONITORING SYSTEM, MODELS EM2, EMR, ES4007, ES4107, ES9005 AND ES9015
| Applicant | Encision, Inc., Boulder CO, US |
| Decision | Substantially Equivalent, Aug 20, 2010 |
| Received | Nov 23, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K093622
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.