510(k) K071364 ยท GZL Electrode, Depth
MICROTARGETING GUIDELINE 4000
| Applicant | FHC, Inc., Bowdoin ME, US |
| Decision | Substantially Equivalent, Jul 25, 2007 |
| Received | May 16, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K071364
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 16, 2010 | FHC, Inc. FHC microTargeting Guideline 4000 ver 1.4 (GL4K) Software,
Catalog # MT-GL4K.
Intended to assist in functional neurological procedures. Terminated |
GZL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.