510(k) K183123 ยท GZL Electrode, Depth
microTargeting Guideline 4000 5.0 System
| Applicant | FHC, Inc., Bowdoin ME, US |
| Decision | Substantially Equivalent, Dec 20, 2018 |
| Received | Nov 13, 2018 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K183123
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 17, 2020 | FHC, Inc. FHC Guideline 4000 5.0 GL5 Main Processing Unit - Product Usage: intended to record and stimulate electrophysiological activity, as well as aid in the accurate placement of electrodes and other instr Terminated |
GZL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.