BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    MRI Patient Monitor TeslaDUO

    Reg #: 8043459 · FEI: 3004117725 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    MIPM Mammendorfer Institut fur Physik und Medizin GmbH
    Registration Number
    8043459
    FEI Number
    3004117725
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Oskar-von-Miller Str. 6-7
    City
    MAMMENDORF/MUNICH Bavaria
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K153739

    Owner / Operator

    Firm Name
    MIPM Mammendorfer Institut fur Physik und Medizin GmbH
    Operator Number
    9001715
    Address
    OSKAR-VON-MILLER STR. 6-7
    City
    MAMMENDORF/MUNICH
    State
    Bavaria
    Postal Code
    82291
    Country
    DE

    US Agent

    Business Name
    Emergo Global Representation LLC
    Contact Name
    Yong Sun
    Address
    2500 Bee Cave Rd., Bldg. 1, Ste. 300
    City
    Austin
    State
    TX
    ZIP
    78746
    Country
    US
    Email
    [email protected]
    Phone
    512 3279997

    Products

    Device Name Product Code
    Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) MWI

    Proprietary Names

    MRI Patient Monitor TeslaDUO Tesla DUO

    Establishment Types

    Manufacture Medical Device