510(k) K925640 ยท ETN Stimulator, Nerve
XOMED-TREACE EMG ENDOTRACHEAL TUBEEN
| Applicant | Xomed-Treace, Inc., Jacksonville FL, US |
| Decision | Substantially Equivalent, Aug 17, 1993 |
| Received | Nov 9, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K925640
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 1, 2022 | Medtronic Xomed, Inc. NIM EMG Endotracheal Tube, Part Numbers:
a) REF 8229308
b) REF 8229307
c) REF 8229306 Open, Classified |
ETN | None listed |
| Jun 28, 2016 | Medtronic Xomed, Inc. NIM EMG Endotracheal Tube, 6.0 mm I.D. x 8.8 mm O.D. (27 FR), Reinforced, Sterile, Rx only. Individually packaged. Terminated |
ETN | None listed |
| Dec 15, 2004 | Medtronic Xomed, Inc. Brand name:
NIM EMG Endotracheal Tube REF 82-29106, 82-29107, 82-29108
NIM EMG Reinforced Endotracheal Tube REF 82-29306, 82-29307, 82-29308
[ Terminated |
ETN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.