BEUDAMED
    FDA Registration Active 🇮🇪 Ireland

    INVOS PM7100 Patient Monitor, INVOS Pediatric rSO2 Sensor, INVOS Infant Regional Saturation Sensor

    Reg #: 8020893 · FEI: 3002807850 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Covidien
    Registration Number
    8020893
    FEI Number
    3002807850
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Michael Collins Road, H91 W9N4 Mervue
    City
    - Galway
    Country
    IE

    Regulatory Submissions

    510(k) Number
    K211561

    Owner / Operator

    Firm Name
    Covidien llc
    Operator Number
    1282497
    Address
    15 HAMPSHIRE STREET, --
    City
    Mansfield
    State
    MA
    Postal Code
    02048
    Country
    US

    US Agent

    Business Name
    Medtronic formerly Covidien
    Contact Name
    Kae Miller
    Address
    6135 Gunbarrel Ave
    City
    Boulder
    State
    CO
    ZIP
    80301
    Country
    US
    Email
    [email protected]
    Phone
    303 4008142

    Products

    Device Name Product Code
    Cerebral Oximeter QEM
    Oximeter, Tissue Saturation MUD

    Proprietary Names

    INVOS PM7100 Patient Monitor, INVOS Pediatric rSO2 Sensor, INVOS Infant Regional Saturation Sensor INVOS™ rSO2 Micro-module (PMC71VP-GE)

    Establishment Types

    Manufacture Medical Device