The following data is part of a premarket notification filed by Bontech Co. Ltd with the FDA for Bsd3543w.
| Device ID | K200787 |
| 510k Number | K200787 |
| Device Name: | BSD3543W |
| Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
| Applicant | Bontech Co. Ltd Digital Empire D-Bldg #1201, Deogyeong-daero 1556 Beon-gil, Yeongtong-gu Suwon-si, KR 443-702 |
| Contact | Ki Chan Ahn |
| Correspondent | Dave Kim Mtech Group 7707 Fannin St Ste 200 Houston, TX 77054 |
| Product Code | MQB |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-03-26 |
| Decision Date | 2020-04-23 |