The following data is part of a premarket notification filed by Huvitz Co., Ltd. with the FDA for Huvitz Imaging System.
| Device ID | K191615 |
| 510k Number | K191615 |
| Device Name: | Huvitz Imaging System |
| Classification | System, Image Management, Ophthalmic |
| Applicant | Huvitz Co., Ltd. 38, Burim-ro, 170beon-gil, Dongan-gu Anyang-si, Dongan-gu, KR 14055 |
| Contact | Hyung Min Heo |
| Correspondent | Dave Kim MTech Group 8310 Buffalo Speedway Houston, TX 77025 |
| Product Code | NFJ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-06-18 |
| Decision Date | 2019-07-18 |