BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Monarch Tower (MON-000006 - 210-001896-00)

    Reg #: 3017425975 · FEI: 3017425975 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    17
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Auris Health, Inc
    Registration Number
    3017425975
    FEI Number
    3017425975
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    5490 Great America Pkwy
    City
    Santa Clara
    State
    CA
    ZIP
    95054
    Country
    US

    Regulatory Submissions

    510(k) Number
    K193534

    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 Tower (MON-000006 - 210-001896-00) Bronchoscope Sheath Valve (MBR-000020) Navigation Patient Patches (MBR-000016) Monarch Bronchoscope (MBR-000211-A) Monarch Pre-op Planning System Kit (MON-000707) Monarch Navigation Field Generator (MON-000006 - 210-000344-00) Bronchoscope Patient Introducer Kit (MBR-000017) Bronchoscope Patient Introducer Mount (MON-000006 - 210-000346-00) Monarch Controller (MON-000706) Biopsy Forceps - Smooth Cup (MBR-000014) Monarch Navigation Patient Sensors (MON-000705) Bronchoscope Fluidics Tubing (MBR-000218) Monarch Cart (MON-000006 - 210-001887-00) Monarch Navigation Field Generator Mount (MON-000006 - 210-000343-00) Monarch Advanced Imaging Accessory Kit (MON-000709) Cytology Brush (MBR-000015) Monarch Pre-Op Planning System Kit (MON-000708)

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility