The following data is part of a premarket notification filed by Vatech Co., Ltd with the FDA for Ezray Air 2 Wall (model: Vex-s350w).
| Device ID | K223058 |
| 510k Number | K223058 |
| Device Name: | EzRay Air 2 Wall (Model: VEX-S350W) |
| 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 7505 Fannin Street, Suite 610 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 | 2022-09-30 |
| Decision Date | 2022-10-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800016401929 | K223058 | 000 |
| 08800016401912 | K223058 | 000 |
| 08800016401905 | K223058 | 000 |