Data / Medical devices / United States / Eargo Inc
Eargo Inc: FDA-registered device maker in San Jose, CA, United States, 1 510(k) clearance
Eargo Inc is registered with the FDA (registration 3010841212) in San Jose, CA, United States. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated December 21, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010841212
- Address
- 2665 North First Street, Suite 300, San Jose, CA, United States, 95134
- Owner or operator
- Eargo Inc. (10046526)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- January 25, 2021
- Registered through
- 2026
- Brand names listed
- Eargo 5, Eargo 6, Eargo 7, Eargo 7-Rx, Eargo 8, Eargo SE, Eargo SE-RX, Link by Eargo
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter | QUG | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Hearing Aid, Air-Conduction With Wireless Technology, Prescription | OSM | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Self-Fitting Air-Conduction Hearing Aid, Over The Counter | QUH | 2 | Complaint file establishment, 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 |
|---|---|---|---|---|---|---|
| December 21, 2022 | K221698 | Eargo 5 , Eargo 6 | QUH | Substantially Equivalent | Eargo, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Hearing Aid, Air-Conduction With Wireless Technology, Prescription
- All makers of Self-Fitting Air-Conduction Hearing Aid, Over The Counter
- All makers of Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter
Updated December 21, 2022. 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.