The following data is part of a premarket notification filed by Vatech Co., Ltd with the FDA for Ezray Air (model Vex-p300).
| Device ID | K161063 |
| 510k Number | K161063 |
| Device Name: | EzRay Air (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 Mtech Group 8310 Buffalo Speedway Houston, TX 77025 |
| Product Code | EHD |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-04-15 |
| Decision Date | 2016-09-01 |
| Summary: | summary |