FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
Dexus Prosthetics System (Model: MSL1, MSR1)
K Number: K220002
·
Decision Sep 9, 2022
Classifications
1
FEI Numbers
243
Registration Numbers
243
Same Product Code
436
Applicant Total
1
Review Days
248
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Basic Information
- Device Name
- Dexus Prosthetics System (Model: MSL1, MSR1)
- K Number
- K220002
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1320
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Zhejiang Qiangnao Technology Co.,Ltd
- Date Received
- January 4, 2022
- Decision Date
- September 9, 2022
- Product Code
- GXY
- 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 |
|---|---|---|---|
| GXY | Electrode, Cutaneous | FDA class 2 | Neurology |
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