K230320
- 510(k) number
- K230320
- Device name
- NIM Standard Reinforced EMG Endotracheal Tube; CONTACT Reinforced EMG Endotracheal Tube
- Applicant
- Medtronic Xomed, Inc. FL · US
- Product code
- ETN — Stimulator, Nerve
- Decision date
- 2023-10-26
- Date received
- 2023-02-06
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Ear, Nose, Throat
PDFDownload 510(k) SummaryArchived here · 0.3 MB · U.S. public domain
Also available from FDA: K230320.pdf
Official FDA record: K230320
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.