The following data is part of a premarket notification filed by Huvitz Co., Ltd. with the FDA for Huvitz Imaging System.
| Device ID | K161829 |
| 510k Number | K161829 |
| Device Name: | Huvitz Imaging System |
| Classification | System, Image Management, Ophthalmic |
| Applicant | HUVITZ CO., LTD. GONGDAN-RO Gunpo-si, KR 435-862 |
| Contact | Kim Eun-jo |
| Correspondent | Dave Kim MTECH GROUP 8310 BUFFALO SPEEDWAY Houston, TX 77025 |
| Product Code | NFJ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-07-05 |
| Decision Date | 2017-04-06 |