FDA 510(k)
FDA class 2
Substantially Equivalent
🇯🇵 Japan
Canon non-mydriatic retinal camera CR series
K Number: K201122
·
Decision Jul 23, 2020
Classifications
1
FEI Numbers
65
Registration Numbers
66
Same Product Code
155
Applicant Total
43
Review Days
87
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Basic Information
- Device Name
- Canon non-mydriatic retinal camera CR series
- K Number
- K201122
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 886.1120
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Canon, Inc.
- Date Received
- April 27, 2020
- Decision Date
- July 23, 2020
- 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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