510(k) K202097
K202097 is an FDA 510(k) premarket notification submitted by Huvitz Co., Ltd. for the device "Fundus Camera". The FDA issued a decision of Substantially Equivalent on February 2, 2021. The device falls under product code HKI (Camera, Ophthalmic, Ac-Powered), a Class II device regulated under 21 CFR 886.1120. Huvitz Co., Ltd. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 2, 2021
- Date Received
- July 29, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Camera, Ophthalmic, Ac-Powered
- Device Class
- Class II
- Regulation Number
- 886.1120
- Review Panel
- OP
- Submission Type