FDA 510(k)
FDA class 2
Substantially Equivalent
🇯🇵 Japan
Kowa SL-19
K Number: K222372
·
Decision Nov 21, 2022
Classifications
1
FEI Numbers
54
Registration Numbers
55
Same Product Code
107
Applicant Total
3
Review Days
108
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Basic Information
- Device Name
- Kowa SL-19
- K Number
- K222372
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.1850
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Kowa Company , Ltd.
- Date Received
- August 5, 2022
- Decision Date
- November 21, 2022
- Product Code
- HJO
- Advisory Committee
- Ophthalmic
- Review Advisory Committee
- OP
- 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 |
|---|---|---|---|
| HJO | Biomicroscope, Slit-Lamp, Ac-Powered | FDA class 2 | Ophthalmic |
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