NEUROVISION INK PRINTED ENDOTRACHEAL TUBE ELECTRODE
FDA 510(k) clearance K110989 · decided 2011-11-03
Clearance details
- K-number
- K110989
- Device name
- NEUROVISION INK PRINTED ENDOTRACHEAL TUBE ELECTRODE
- Applicant
- Neurovision Medical Products, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2011-04-08
- Decision date
- 2011-11-03
- Days to decision
- 209 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
- Ventura, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Cobra, 3-Plate EMG ET Tube, 6.0mm, REF: LTE7003PM, not made with natural rubber latex, Rx recall (Z-2719-2024) | Neurovision Medical Products Inc | 2024-08-23 |