BEUDAMED
    FDA Registration Active 🇸🇪 Sweden

    MR850

    Reg #: 8010042 · FEI: 3002808128 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    MAQUET CRITICAL CARE AB
    Registration Number
    8010042
    FEI Number
    3002808128
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    ROENTGENVAGEN 2
    City
    SOLNA Stockholm
    Country
    SE

    Regulatory Submissions

    510(k) Number
    K033710

    Owner / Operator

    Firm Name
    Maquet Critical Care AB
    Operator Number
    8010042
    Address
    ROENTGENVAGEN 2
    City
    SOLNA
    State
    Stockholm
    Postal Code
    SE-17154
    Country
    SE

    Products

    Device Name Product Code
    Humidifier, Respiratory Gas, (Direct Patient Interface) BTT

    Proprietary Names

    MR850

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device