Data / Medical devices / Taiwan / Ostar Meditech Corp.
Ostar Meditech Corp.: FDA-registered device maker in New Taipei City, Taiwan, 2 510(k) clearances
Ostar Meditech Corp. is registered with the FDA (registration 3004918630) in New Taipei City, Taiwan. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated October 20, 2011. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3004918630
- Address
- 5F, NO. 46-4, MIN-QUAN RD. XIN-DIAN Dist., New Taipei City, Taiwan, 231023
- Owner or operator
- OSTAR MEDITECH CORP. (9075201)
- Roles
- Manufacturer
- First device listed
- January 25, 2008
- Registered through
- 2026
- Brand names listed
- OSTAR
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | 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 |
|---|---|---|---|---|---|---|
| October 20, 2011 | K112269 | OSTAR USB BLOOD PRESSURE MONITOR WITH SPECTRUM / P200 FOR UPPER ARM, AND M100 FOR WRIST TYPE | DXN | Substantially Equivalent | OSTAR MEDITECH CORP. | accessdata.fda.gov |
| May 13, 2005 | K050680 | BLOOD PRESSURE MONITOR WITH SPECTRUM/P2, X2, A2, AND K7 | DXN | Substantially Equivalent | OSTAR MEDITECH CORP. | accessdata.fda.gov |
Compare with other makers
Updated October 20, 2011. 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.