FDA 510(k)
FDA class 2
Substantially Equivalent
🇫🇷 France
KEOPS Balance Analyzer 3D
K Number: K213975
·
Decision May 6, 2022
Classifications
1
FEI Numbers
599
Registration Numbers
599
Same Product Code
2271
Applicant Total
10
Review Days
137
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Basic Information
- Device Name
- KEOPS Balance Analyzer 3D
- K Number
- K213975
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- S.M.A.I.O
- Date Received
- December 20, 2021
- Decision Date
- May 6, 2022
- Product Code
- LLZ
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- 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 |
|---|---|---|---|
| LLZ | System, Image Processing, Radiological | FDA class 2 | Radiology |
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