FDA 510(k)
FDA class 2
Substantially Equivalent
🇯🇵 Japan
KOWA DR-1a
K Number: K190573
·
Decision Jun 4, 2019
Classifications
1
FEI Numbers
67
Registration Numbers
68
Same Product Code
151
Applicant Total
3
Review Days
90
Basic Information
- Device Name
- KOWA DR-1a
- K Number
- K190573
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.1120
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Kowa Company, Ltd.
- Date Received
- March 6, 2019
- Decision Date
- June 4, 2019
- Product Code
- HKI
- 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 |
|---|---|---|---|
| HKI | Camera, Ophthalmic, Ac-Powered | FDA class 2 | Ophthalmic |
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