Data / Medical devices / United States / CGX, LLC
CGX, LLC: FDA-registered device maker in San Diego, CA, United States, 1 510(k) clearance
CGX, LLC is registered with the FDA (registration 3015614098) in San Diego, CA, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated May 20, 2021. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3015614098
- Address
- 8445 Camino Santa Fe Suite 213, San Diego, CA, United States, 92121
- Owner or operator
- CGX, LLC (10082575)
- Roles
- Specification developer
- First device listed
- August 17, 2021
- Registered through
- 2026
- Brand names listed
- Quick-20m
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Amplifier, Physiological Signal | GWL | 2 | Specification developer | accessdata.fda.gov |
| 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 20, 2021 | K203331 | Quick-20m | GWL | Substantially Equivalent | Cgx, LLC | accessdata.fda.gov |
Compare with other makers
Updated May 20, 2021. 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.