Data / Medical devices / United States / Spectros Medical Devices Inc
Spectros Medical Devices Inc: FDA-registered device maker in Houston, TX, United States, 3 510(k) clearances
Spectros Medical Devices Inc is registered with the FDA (registration 3004957206) in Houston, TX, United States. It lists 3 device types. The FDA files 3 510(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
- 3004957206
- Address
- 2211 Norfolk St #1110, Houston, TX, United States, 77098
- Owner or operator
- Spectros Medical Devices Inc (9062042)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- December 17, 2007
- Registered through
- 2026
- Brand names listed
- T-stat
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Medical Device Data System | OUG | 1 | Complaint file establishment | accessdata.fda.gov |
| Oximeter, Tissue Saturation | MUD | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Stand, Infusion | FOX | 1 | Complaint file establishment, 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 |
| November 5, 2004 | K040684 | T-STAT MICROVASCULAR TISSUE OXIMETER, MODEL 303 | MUD | Substantially Equivalent | Spectros Corporation | accessdata.fda.gov |
Compare with other makers
- All makers of Medical Device Data System
- All makers of Stand, Infusion
- All makers of Oximeter, Tissue Saturation
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.