The following data is part of a premarket notification filed by Vatech Co., Ltd with the FDA for Ezray Air Portable (model: Vex-p300).
| Device ID | K200182 |
| 510k Number | K200182 |
| Device Name: | EzRay Air Portable (Model: VEX-P300) |
| Classification | Unit, X-ray, Extraoral With Timer |
| Applicant | Vatech Co., Ltd 13, Samsung 1-ro 2-gil Hwaseong-si, KR 18449 |
| Contact | Daniel Kim |
| Correspondent | Dave Kim MtechGroup 7707 Fannin St., Ste. 200-Vlll Houston, TX 77054 |
| Product Code | EHD |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-01-24 |
| Decision Date | 2020-02-11 |