The following data is part of a premarket notification filed by Livermoretech Inc. with the FDA for Ezer, Portable X-ray System.
| Device ID | K190935 |
| 510k Number | K190935 |
| Device Name: | EZER, Portable X-ray System |
| Classification | Unit, X-ray, Extraoral With Timer |
| Applicant | Livermoretech Inc. 801 North Jupiter Rd, Suite 200 Plano, TX 75074 |
| Contact | Jae Hong 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 | 2019-04-10 |
| Decision Date | 2019-12-19 |