The following data is part of a premarket notification filed by Hdt Co., Ltd with the FDA for Mine Alnu (model: Mine 2.1).
| Device ID | K213405 |
| 510k Number | K213405 |
| Device Name: | MINE ALNU (Model: Mine 2.1) |
| Classification | System, X-ray, Mobile |
| Applicant | HDT Co., Ltd # 202-ho, 29, Uchi-ro 880beon-gil, Buk-gu Gwangju, KR 61042 |
| Contact | Sung Hee Chun |
| Correspondent | Dave Kim Mtech Group 7505 Fannin St. Suite 610 Houston, TX 77054 |
| Product Code | IZL |
| CFR Regulation Number | 892.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-10-19 |
| Decision Date | 2022-07-10 |