510(k) K913625 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
ELECTROSCOPE MONITOR, EM-1
| Applicant | Electroscope, Inc., Boulder CO, US |
| Decision | Substantially Equivalent, Dec 30, 1991 |
| Received | Aug 15, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K913625
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 22, 2004 | Encision, Inc. Encision ES4107 Disposable AEM Cord, Sterile. Terminated |
GEI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.