Data / Medical devices / United States / Blue Spark Technologies, Inc.
Blue Spark Technologies, Inc.: FDA-registered device maker in Westlake, OH, United States, 2 510(k) clearances
Blue Spark Technologies, Inc. is registered with the FDA (registration 3011243696) in Westlake, OH, United States. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated December 3, 2020. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3011243696
- FEI number
- 3017147080
- Address
- 806 Sharon DR Ste G, Westlake, OH, United States, 44145
- Owner or operator
- Blue Spark Technologies, Inc. (10049257)
- Roles
- Manufacturer, Specification developer
- First device listed
- December 7, 2015
- Registered through
- 2026
- Brand names listed
- TempTraq
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Continuous Measurement Thermometer | FLL | 2 | Manufacturer, Specification developer | 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 |
|---|---|---|---|---|---|---|
| December 3, 2020 | K201977 | TempTraq | FLL | Substantially Equivalent | Blue Spark Technologies, Inc. | accessdata.fda.gov |
| September 2, 2015 | K143267 | TempTraq TT-100 | FLL | Substantially Equivalent | Blue Spark Technologies, Inc. | accessdata.fda.gov |
Compare with other makers
Updated December 3, 2020. 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.