BEUDAMED
    FDA Registration Active 🇺🇸 United States

    FondCircle Wrist Blood Pressure Monitor FBP-W1

    Reg #: 3034603279 · FEI: 3034603279 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    FONDCIRCLE INC.
    Registration Number
    3034603279
    FEI Number
    3034603279
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    4695 MacArthur Court 11th Floor
    City
    Newport Beach
    State
    CA
    ZIP
    92660
    Country
    US

    Regulatory Submissions

    510(k) Number
    K233130

    Owner / Operator

    Firm Name
    FondCircle Inc.
    Operator Number
    10092209
    Address
    4695 MacArthur Court 11th Floor
    City
    Newport Beach
    State
    CA
    Postal Code
    92660
    Country
    US

    Products

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

    Proprietary Names

    FondCircle Wrist Blood Pressure Monitor FBP-W1

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility