Data / Medical devices / United States / Fogg System Company, Inc.
Fogg System Company, Inc.: FDA-registered device maker in Aurora, CO, United States, 1 510(k) clearance
Fogg System Company, Inc. is registered with the FDA (registration 3001762454) in Aurora, CO, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated November 22, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3001762454
- Address
- 15592 East Batavia Dr, Aurora, CO, United States, 80011
- Owner or operator
- Fogg System Company, Inc. (10089301)
- Roles
- Manufacturer
- First device listed
- November 27, 2023
- Registered through
- 2026
- Brand names listed
- Fogg System Patient Monitoring Cables
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cable, Transducer And Electrode, Patient, (Including Connector) | DSA | 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 |
|---|---|---|---|---|---|---|
| November 22, 2023 | K222712 | Fogg System Patient Monitoring Cables | DSA | Substantially Equivalent | Fogg System Company, Inc. | accessdata.fda.gov |
Compare with other makers
Updated November 22, 2023. 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.