510(k) K991522 ยท GZL Electrode, Depth
MICROTARGETING ELECTRODE
| Applicant | FHC, Inc., Bowdoinham ME, US |
| Decision | Substantially Equivalent, Aug 4, 2000 |
| Received | May 3, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K991522
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 18, 2008 | FHC, Inc. FHC MicroTargeting Electrode, MTDWBP(AR)(MP I )
Intended for use in intra-operative recording of single unit neuronal activity or intra-operative stimulation of neural elements in the brain. Terminated |
GZL | None listed |
| Dec 18, 2008 | FHC, Inc. FC4000 MicroTargeting Electrode Kit 5x
For use with Nexframe and Nexdrive
Distributed by Medtronic Inc., Minneapolis, MN
REF: FCH 4000 (5 Prefilled single use kits -5 packages and 2 electrodes each)
Terminated |
GZL | None listed |
| Dec 18, 2008 | FHC, Inc. FC400SP microTargeting StimPilot Single Procedure Kit
Distributed by Medtronic Inc., Minneapolis, MN
Ref: FHC4000SP
Intended for use in intra-operative recording of single unit neuronal activity or Terminated |
GZL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.