Data / Medical devices / South Korea / Huons Meditech Co., Ltd
Huons Meditech Co., Ltd: FDA-registered device maker in Seongnam-si Gyeonggi, South Korea, 1 510(k) clearance
Huons Meditech Co., Ltd is registered with the FDA (registration 3029915542) in Seongnam-si Gyeonggi, South Korea. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated July 22, 2014. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3029915542
- Address
- #216~219, 314, Galmachi-ro, Jungwon-gu, Seongnam-si, Gyeonggi-do, Republic of Korea, Seongnam-si Gyeonggi, South Korea, 13201
- Owner or operator
- Huons USA (10088996)
- Roles
- Manufacturer
- First device listed
- October 31, 2023
- Registered through
- 2026
- Brand names listed
- ASADAL-M1
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Lithotriptor, Extracorporeal Shock-Wave, Urological | LNS | 2 | 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 |
|---|---|---|---|---|---|---|
| July 22, 2014 | K131721 | EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER, COMED ASADAL-M1 | LNS | Substantially Equivalent | Comed Medical Systems Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated July 22, 2014. 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.