BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Monarch Platform

    Reg #: 3023460764 · FEI: 3023460764 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Auris Health, Inc.
    Registration Number
    3023460764
    FEI Number
    3023460764
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    170 Baytech Drive
    City
    San Jose
    State
    CA
    ZIP
    95134
    Country
    US

    Regulatory Submissions

    510(k) Number
    K211493

    Owner / Operator

    Firm Name
    Auris Health, Inc.
    Operator Number
    10057462
    Address
    5490 Great America Parkway
    City
    Santa Clara
    State
    CA
    Postal Code
    95054
    Country
    US
    Correspondent
    Joy Sacmar

    Products

    Device Name Product Code
    Bronchoscope (Flexible Or Rigid) EOQ
    System, X-Ray, Tomography, Computed JAK

    Proprietary Names

    Monarch Platform

    Establishment Types

    Manufacture Medical Device