FDA 510(k)
FDA class 2
Substantially Equivalent
🇹🇼 Taiwan
NeuroSwift Pro
K Number: K223047
·
Decision Jun 29, 2023
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
57
Applicant Total
1
Review Days
273
Basic Information
- Device Name
- NeuroSwift Pro
- K Number
- K223047
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1460
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Neurobit Technologies Co., Ltd.
- Date Received
- September 29, 2022
- Decision Date
- June 29, 2023
- Product Code
- GWN
- Advisory Committee
- Neurology
- Review Advisory Committee
- EN
- 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 |
|---|---|---|---|
| GWN | Nystagmograph | FDA class 2 | Neurology |
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