BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Ambient Clinical Analytics

    Reg #: 3010692333 · FEI: 3010692333 · Expires 2026
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

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    Registration Details

    Registration Name
    Ambient Clinical Analytics
    Registration Number
    3010692333
    FEI Number
    3010692333
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    221 1st Ave Sw Ste 600
    City
    Rochester
    State
    MN
    ZIP
    55902
    Country
    US

    Regulatory Submissions

    510(k) Number
    K143372

    Owner / Operator

    Firm Name
    Ambient Clinical Analytics
    Operator Number
    10049034
    Address
    221 1st Avenue Southwest, #600
    City
    Rochester
    State
    MN
    Postal Code
    55902
    Country
    US
    Correspondent
    Allen Berning

    Products

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

    Proprietary Names

    AWARE

    Establishment Types

    Manufacture Medical Device