510(k) K112686 ยท ETN Stimulator, Nerve
NEXT GEN EMG ENDOTRACHEAL TUBE
| Applicant | Medtronic Xomed, Inc., Jacksonville FL, US |
| Decision | Substantially Equivalent, Jun 27, 2012 |
| Received | Sep 15, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K112686
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 10, 2024 | Medtronic Xomed, Inc. NIM TriVantage EMG Endotracheal Tubes, Model (REF) Numbers and sizes:
a) 8229706, 6.0MM ID;
b) 8229707, 7.0MM ID;
c) 8229708, 8.0MM ID;
d) 8229736, 6MM ID 3PK;
e) 8229737, 7MM ID 3 PK;
f) 8229738 Open, Classified |
ETN | None listed |
| Dec 22, 2021 | Medtronic Xomed, Inc. NIM TRIVANTAGE EMG Endotracheal Tube Open, Classified |
ETN | None listed |
| Jun 4, 2013 | Medtronic Xomed, Inc. REF 8229705 x1 NIM TriVantage EMG Endotracheal Tube 5.0 mm I.D. x 6.5 mm O.D. Medtronic Xomed, Inc., 6743 Southpoint Drive North, Jacksonville, FL 32216-0980 USA STERILE Rx Only
The electrodes are Terminated |
ETN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.