FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EARP Nerve Cuff Electrode
K Number: K230853
·
Decision Oct 6, 2023
Classifications
1
FEI Numbers
123
Registration Numbers
123
Same Product Code
94
Applicant Total
9
Review Days
192
Basic Information
- Device Name
- EARP Nerve Cuff Electrode
- K Number
- K230853
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.1820
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Nvision Biomedical Technologies, Inc.
- Date Received
- March 28, 2023
- Decision Date
- October 6, 2023
- Product Code
- ETN
- Advisory Committee
- Ear, Nose, Throat
- Review Advisory Committee
- NE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| ETN | Stimulator, Nerve | FDA class 2 | Ear, Nose, Throat |
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|---|---|---|---|
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| K210424 | Quantum Anterior Cervical Plate | Oct 22, 2021 | Substantially Equivalent |
| K203445 | Trigon HA Stand-Alone Wedge Fixation System | Dec 21, 2020 | Substantially Equivalent |
| K193645 | nva, nvp, and nvt | Jan 13, 2020 | Substantially Equivalent |
| K192645 | Trigon Ti Stand-Alone Wedge Fixation System | Dec 23, 2019 | Substantially Equivalent |
| K190380 | nvc | Mar 21, 2019 | Substantially Equivalent |