510(k) K190954
K190954 is an FDA 510(k) premarket notification submitted by Chongqing Bio Newvision Medical Equipment , Ltd. for the device "Fundus Camera". The FDA issued a decision of Substantially Equivalent on Jan 22, 2020. The device falls under product code HKI (Camera, Ophthalmic, Ac-Powered), a Class II device regulated under 21 CFR 886.1120.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 22, 2020
- Date Received
- Apr 11, 2019
- 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
- 510(k)