Data / Medical devices / South Korea / Medicore Co. Ltd.
Medicore Co. Ltd.: FDA-registered device maker in Seongnam-si Gyeonggi, South Korea, 3 510(k) clearances
Medicore Co. Ltd. is registered with the FDA (registration 2000010846) in Seongnam-si Gyeonggi, South Korea. It lists 2 device types. The FDA files 3 510(k) clearances under its listings, the newest dated September 13, 2021. Registered through 2027. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 2000010846
- Address
- No., Joonganginnotech, 148, Sagimakgolro, Jungwon-gu, Seongnam-si Gyeonggi, South Korea, 13207
- Owner or operator
- MEDICORE CO. LTD. (10025245)
- Roles
- Manufacturer
- First device listed
- March 26, 2008
- Registered through
- 2027
- Brand names listed
- Avacen CSS, IRIS-XP, Max Pulse, SA-3000P
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Plethysmograph, Photoelectric, Pneumatic Or Hydraulic | JOM | 2 | Manufacturer | accessdata.fda.gov |
| System, Telethermographic (Adjunctive Use) | LHQ | 1 | 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 |
|---|---|---|---|---|---|---|
| September 13, 2021 | K212412 | IRIS-XP | LHQ | Substantially Equivalent | Medicore Co., Ltd. | accessdata.fda.gov |
| June 13, 2011 | K110374 | MAX PULSE SYSTEM | JOM | Substantially Equivalent | Medicore Co., Ltd. | accessdata.fda.gov |
| November 29, 2007 | K073323 | SA-3000P | JOM | Substantially Equivalent | Medicore Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Telethermographic (Adjunctive Use)
- All makers of Plethysmograph, Photoelectric, Pneumatic Or Hydraulic
Updated September 13, 2021. 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.