510(k) K083124 ยท GWF Stimulator, Electrical, Evoked Response
NIM 3.0
| Applicant | Medtronic Xomed, Inc., Jacksonville FL, US |
| Decision | Substantially Equivalent, Feb 27, 2009 |
| Received | Oct 22, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K083124
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 10, 2012 | Medtronic Xomed, Inc. Interfaces subject to recall:
Medtronic NIM (Nerve Integrity Monitor) 3.0 Patient Interfaces 8253200 (Response)
LABELING:
Box Label: REF 8253200 x1***NIM-Response 3.0 Patient Interface***Medtron Terminated |
GWF | None listed |
| Sep 10, 2012 | Medtronic Xomed, Inc. Interfaces subject to recall:
Medtronic NIM (Nerve Integrity Monitor) 3.0 Patient Interfaces REF 8253410 (Neuro).
LABELING:
Box Label: REF 8253410 x1***NIM-Response 3.0 Patient Interface***Medtr Terminated |
GWF | None listed |
| Sep 10, 2012 | Medtronic Xomed, Inc. Interfaces subject to recall:
Medtronic NIM (Nerve Integrity Monitor) 3.0 Patient Interfaces REF 8253210 (Pulse).
LABELING:
Box Label: REF 8253210 x1***NIM-Response 3.0 Patient Interface***Medtr Terminated |
GWF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.