K190954 is an FDA 510(k) clearance for the Fundus Camera. This device is classified as a Camera, Ophthalmic, Ac-powered (Class II - Special Controls, product code HKI).
Submitted by Chongqing Bio Newvision Medical Equipment , Ltd. (Chongqing, CN). The FDA issued a Cleared decision on January 22, 2020, 286 days after receiving the submission on April 11, 2019.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1120.
| 510(k) Number | K190954 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 11, 2019 |
| Decision Date | January 22, 2020 |
| Days to Decision | 286 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | HKI - Camera, Ophthalmic, Ac-powered |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.1120 |