Data / Medical devices / United States / Concha Inc.
Concha Inc.: FDA-registered device maker in San Mateo, CA, United States, 1 510(k) clearance
Concha Inc. is registered with the FDA (registration 3030627827) in San Mateo, CA, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated March 15, 2024. 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
- 3030627827
- Address
- 55 East 3rd Ave, San Mateo, CA, United States, 94401
- Owner or operator
- Concha Inc. (10090365)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- March 18, 2024
- Registered through
- 2026
- Brand names listed
- Concha Sol Hearing Aids (CL-1001)
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Self-Fitting Air-Conduction Hearing Aid, Over The Counter | QUH | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Self-Fitting Air-Conduction Hearing Aid, Prescription | QDD | 2 | Complaint file establishment, 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 |
|---|---|---|---|---|---|---|
| March 15, 2024 | K233747 | Concha Sol Hearing Aids (CL-1001) | QUH | Substantially Equivalent | Concha Labs | accessdata.fda.gov |
Compare with other makers
- All makers of Self-Fitting Air-Conduction Hearing Aid, Prescription
- All makers of Self-Fitting Air-Conduction Hearing Aid, Over The Counter
Updated March 15, 2024. 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.