BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Omada Health Blood Pressure Monitor

    Reg #: 3015236197 · FEI: 3015236197 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    OMADA HEALTH
    Registration Number
    3015236197
    FEI Number
    3015236197
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    500 Sansome St, Suite 200
    City
    San Francisco
    State
    CA
    ZIP
    94111
    Country
    US

    Regulatory Submissions

    510(k) Number
    K131395

    Owner / Operator

    Firm Name
    Omada Health
    Operator Number
    10059585
    Address
    500 Sansome St, Suite 200
    City
    San Francisco
    State
    CA
    Postal Code
    94111
    Country
    US
    Correspondent
    Patrick Curry

    Products

    Device Name Product Code
    System, Measurement, Blood-Pressure, Non-Invasive DXN

    Proprietary Names

    Omada Health Blood Pressure Monitor

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198