Data / Medical devices / United States / Gereonics, Inc.
Gereonics, Inc.: FDA-registered device maker in Irvine, CA, United States, 3 510(k) clearances
Gereonics, Inc. is registered with the FDA (registration 2025694) in Irvine, CA, United States. It lists 4 device types. The FDA files 3 510(k) clearances under its listings, the newest dated January 12, 2005. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2025694
- Address
- 117 Sanctuary, Irvine, CA, United States, 92620
- Owner or operator
- GEREONICS, INC. (2025694)
- Roles
- Manufacturer, Specification developer
- First device listed
- August 20, 2007
- Registered through
- 2026
- Brand names listed
- BraiNet, BriaNet, GEREONICS BIOPOTENTIAL SKIN ELECTRODES, GEREONICS ULTRA-PIEZO LIMB MOVEMENT SENSOR, GEREONICS ULTRA-PIEZO RESPIRATORY EFFORT SENSOR
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Electrode, Cutaneous | GXY | 2 | Specification developer | accessdata.fda.gov |
| Electrode, Electrocardiograph | DRX | 2 | Manufacturer | accessdata.fda.gov |
| Electrode, Needle | GXZ | 2 | Specification developer | accessdata.fda.gov |
| Monitor, Breathing Frequency | BZQ | 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 |
|---|---|---|---|---|---|---|
| January 12, 2005 | K043009 | BRAINET KIT | GXY | Substantially Equivalent | Jordan Neuroscience, Inc. | accessdata.fda.gov |
| February 8, 1999 | K983449 | GEREONICS ULTRA-PIEZO RESPIRATORY EFFORT SENSOR | BZQ | Substantially Equivalent | Gereonics, Inc. | accessdata.fda.gov |
| August 6, 1986 | K861099 | GEREONICS BIOPOTENTIAL SKIN ELECTRODES | DRX | Substantially Equivalent | Gereonics, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Electrode, Cutaneous
- All makers of Electrode, Needle
- All makers of Electrode, Electrocardiograph
- All makers of Monitor, Breathing Frequency
Updated January 12, 2005. 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.