BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Monarch Cart (MON-000008 - 210-007592)

    Reg #: 3023460764 · FEI: 3023460764 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    18
    Establishment Types
    2
    Classifications
    3

    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
    K243219

    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
    System, X-Ray, Tomography, Computed JAK
    Reprocessed Bronchoscope QNW
    Bronchoscope (Flexible Or Rigid) EOQ

    Proprietary Names

    Monarch Cart (MON-000008 - 210-007592) Monarch Bronchoscope (MBR-000211-A) Monarch Advanced Imaging Accessory Kit (MON-000709); Cytology Brush (MBR-000015) Monarch Navigation Field Generator Mount (210-000343-00) System, x-ray, tomography, computed - Monarch Platform (MON-000008) Monarch Navigation Patient Patches (MBR-000016) MON-000710 Monarch Pre-Op Planning System Kit Bronchoscope (flexible or rigid) - Monarch Platform (MON-000008) Monarch Navigation Field Generator (210-000344-00) Monarch Controller (MON-000712) Monarch Tower (MON-000008) 210-007591-00 Monarch Navigation Patient Sensors (MON-000705) Bronchoscope Patient Introducer Mount (210-000346-00) Bronchoscope Patient Introducer Kit (MBR-000017) Bronchoscope (flexible or rigid) - Biopsy Forceps - Smooth Cup (MBR-000014); Bronchoscope Sheath Valve (MBR-000020) Bronchoscope Fluidics Tubing (MBR-000218)

    Establishment Types

    Repack or Relabel Medical Device Manufacture Medical Device