The following data is part of a premarket notification filed by Huvitz Co., Ltd. with the FDA for Fundus Camera.
| Device ID | K202097 |
| 510k Number | K202097 |
| Device Name: | Fundus Camera |
| Classification | Camera, Ophthalmic, Ac-powered |
| Applicant | Huvitz Co., Ltd. 38, 170 Beon-Gil, Dongan-Gu Anyang-si, KR 14055 |
| Contact | Hyung Min Heo |
| Correspondent | Dave Kim Mtech Group 7707 Fannin St. Ste 200 Houston, TX 77054 |
| Product Code | HKI |
| CFR Regulation Number | 886.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-07-29 |
| Decision Date | 2021-02-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800019600541 | K202097 | 000 |