BEUDAMED
    FDA Registration Active 🇺🇸 United States

    EARGO INC

    Reg #: 3010841212 · FEI: 3010841212 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    8
    Establishment Types
    2
    Classifications
    3

    Registration Details

    Registration Name
    EARGO INC
    Registration Number
    3010841212
    FEI Number
    3010841212
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    2665 North First Street, Suite 300
    City
    San Jose
    State
    CA
    ZIP
    95134
    Country
    US

    Regulatory Submissions

    510(k) Number
    K221698

    Owner / Operator

    Firm Name
    Eargo Inc.
    Operator Number
    10046526
    Address
    2665 North First Street, Suite 300
    City
    San Jose
    State
    CA
    Postal Code
    95134
    Country
    US
    Correspondent
    RAQA Eargo

    Products

    Device Name Product Code
    Self-Fitting Air-Conduction Hearing Aid, Over The Counter QUH
    Hearing Aid, Air-Conduction With Wireless Technology, Prescription OSM
    Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter QUG

    Proprietary Names

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

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device