FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
Nerivio
K Number: K223169
·
Decision Feb 6, 2023
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
6
Applicant Total
4
Review Days
118
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Basic Information
- Device Name
- Nerivio
- K Number
- K223169
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5899
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Theranica Bioelectronics , Ltd.
- Date Received
- October 11, 2022
- Decision Date
- February 6, 2023
- Product Code
- QGT
- Advisory Committee
- Neurology
- 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 |
|---|---|---|---|
| QGT | Distal Transcutaneous Electrical Stimulator For Treatment Of Acute Migraine | FDA class 2 | Neurology |
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