Data / Medical devices / South Korea / Bontech Co., Ltd
Bontech Co., Ltd: FDA-registered device maker in Suwon-si Gyeonggi, South Korea, 3 510(k) clearances
Bontech Co., Ltd is registered with the FDA (registration 3013599033) in Suwon-si Gyeonggi, South Korea. It lists 1 device type. The FDA files 3 510(k) clearances under its listings, the newest dated April 23, 2020. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3013599033
- Address
- Digital Empire D #1201,16, Deogyeong-daero,1556 beon-gil Youngtong-gu Youngtong-dong 980-3, Suwon-si Gyeonggi, South Korea, 443702
- Owner or operator
- Bontech Co., Ltd (10062226)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- December 30, 2019
- Registered through
- 2027
- Brand names listed
- BSD3543, BSD3543 Digital Flat Panel X-ray Detector, BSD3543W, BSD4343R, BSD4343R Digital Flat Panel X-ray Detector, BT-DA22-IA(CsI), BT-DA22W (CsI), BT-DA24-IA(CsI) and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Solid State X-Ray Imager (Flat Panel/Digital Imager) | MQB | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 23, 2020 | K200787 | BSD3543W | MQB | Substantially Equivalent | Bontech Co., Ltd. | accessdata.fda.gov |
| June 21, 2017 | K171485 | BSD4343R Digital Flat Panel X-ray Detector | MQB | Substantially Equivalent | Bontech, Inc. | accessdata.fda.gov |
| October 14, 2016 | K162487 | BSD3543 Digital Flat Panel X-ray Detector | MQB | Substantially Equivalent | Bontech, Inc. | accessdata.fda.gov |
Compare with other makers
Updated April 23, 2020. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.