Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010841212

FEI Number

3010841212

Entity Name

EARGO INC

City/State/Country

San Jose, CA, US

Establishment Address

2665 North First Street, Suite 300, San Jose, CA 95134, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

Owner / Operator

Eargo Inc. (Owner Number: 10046526)

Owner / Operator Contact Address

2665 North First Street, Suite 300, San Jose, CA 95134, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Eargo 6 Eargo SE Eargo 7 Eargo 5 Eargo 8 Eargo SE-RX Eargo 7-Rx Link by Eargo

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QUH	Self-Fitting Air-Conduction Hearing Aid, Over The Counter	Ear, Nose, Throat	Class 2	874.3325	2023-02-07
OSM	Hearing Aid, Air-Conduction With Wireless Technology, Prescription	Ear, Nose, Throat	Class 2	874.3305	2021-01-25
QUG	Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter	Ear, Nose, Throat	Class 2	874.3305	2023-12-01

Official Correspondent

RAQA Eargo

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Eargo Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010841212. Last updated year: 2026. Please use registration number 3010841212 when referencing this establishment in official correspondence.