Data / Medical devices / United States / Columbia Scientific Development, LLC
Columbia Scientific Development, LLC: FDA-registered device maker in Portland, OR, United States, 1 510(k) clearance
Columbia Scientific Development, LLC is registered with the FDA (registration 3012321270) in Portland, OR, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated May 30, 2008. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3012321270
- Address
- 2529 NE 7th Avenue, Portland, OR, United States, 97212
- Owner or operator
- Columbia Scientific Development, LLC (10045177)
- Roles
- Specification developer
- First device listed
- October 25, 2013
- Registered through
- 2026
- Brand names listed
- Columbia 600, Columbia 700
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Electrode, Cutaneous | GXY | 2 | 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 |
|---|---|---|---|---|---|---|
| May 30, 2008 | K080386 | COLUMBIA 600 ELECTRODE, COLUMBIA 06 LEADWIRE | GXY | Substantially Equivalent | Columbia Scientific Development, LLC | accessdata.fda.gov |
Compare with other makers
Updated May 30, 2008. 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.