510(k) K924226 ยท GYC Electrode, Cortical
OJEMANN CORTICAL STIMULATOR
| Applicant | Radionics, Inc., Burlington MA, US |
| Decision | Substantially Equivalent, Apr 21, 1993 |
| Received | Aug 21, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K924226
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 1, 2013 | Integra Burlington MA, Inc. Integra Ojemann Cortical Stimulator; Product / Catalogue No: OCS2.
Intended for intraoperative cortical stimulation mapping procedures. Terminated |
GYC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.