Data / Medical devices / United States / Qostronics Inc
Qostronics Inc: FDA-registered device maker in San Jose, CA, United States, 2 510(k) clearances
Qostronics Inc is registered with the FDA (registration 3008717564) in San Jose, CA, United States. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated September 23, 2019. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3008717564
- Address
- 2044 Corporate Court, San Jose, CA, United States, 95131
- Owner or operator
- QOSTRONICS INC (10054963)
- Roles
- Manufacturer
- First device listed
- May 18, 2017
- Registered through
- 2026
- Brand names listed
- Oximeter, tissue saturation, T-STAT 2 Microvascular Tissue Oximeter
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Oximeter, Tissue Saturation | MUD | 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 |
|---|---|---|---|---|---|---|
| September 23, 2019 | K192322 | T-Stat 2.0 Microvascular Tissue Oximeter | MUD | Substantially Equivalent | Spectros Corporation | accessdata.fda.gov |
| July 28, 2008 | K081233 | T-STAT 303 ISCHEMIA MONITORING SYSTEM | MUD | Substantially Equivalent | Spectros Corporation | accessdata.fda.gov |
Compare with other makers
Updated September 23, 2019. 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.