XOMED-TREACE EMG ENDOTRACHEAL TUBEEN
FDA 510(k) clearance K925640 · decided 1993-08-17
Clearance details
- K-number
- K925640
- Device name
- XOMED-TREACE EMG ENDOTRACHEAL TUBEEN
- Applicant
- Xomed-Treace, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1992-11-09
- Decision date
- 1993-08-17
- Days to decision
- 281 days
- Clearance type
- Traditional
- Product code
- ETN
- Device class
- 2
- Regulation number
- 874.1820
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Jacksonville, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| NIM EMG Endotracheal Tube, Part Numbers: a) REF 8229308 b) REF 8229307 c) REF 8229306 recall (Z-1520-2022) | Medtronic Xomed, Inc. | 2022-09-01 |
| Brand name: NIM EMG Endotracheal Tube REF 82-29106, 82-29107, 82-29108 NIM EMG Reinforced recall (Z-0310-05) | Medtronic Xomed, Inc. | 2004-12-15 |