The following data is part of a premarket notification filed by Vatech Co., Ltd. with the FDA for Dental Extraoral Source X-ray System (esx).
| Device ID | K092103 |
| 510k Number | K092103 |
| Device Name: | DENTAL EXTRAORAL SOURCE X-RAY SYSTEM (ESX) |
| Classification | Unit, X-ray, Extraoral With Timer |
| Applicant | VATECH CO., LTD. 256 NORTH SAM HOUSTON PKWY E. SUITE 115 Houston, TX 77060 |
| Contact | Vincent Lee |
| Correspondent | Vincent Lee VATECH CO., LTD. 256 NORTH SAM HOUSTON PKWY E. SUITE 115 Houston, TX 77060 |
| Product Code | EHD |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-07-14 |
| Decision Date | 2009-10-09 |
| Summary: | summary |