FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
Fundus Camera
K Number: K202097
·
Decision Feb 2, 2021
Classifications
1
FEI Numbers
65
Registration Numbers
66
Same Product Code
155
Applicant Total
6
Review Days
188
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Basic Information
- Device Name
- Fundus Camera
- K Number
- K202097
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.1120
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Huvitz Co., Ltd.
- Date Received
- July 29, 2020
- Decision Date
- February 2, 2021
- 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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| K073190 | SLIT LAMP | Jan 11, 2008 | Substantially Equivalent |