BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Arboleaf Upper Arm Blood Pressure Monitor SP10A

    Reg #: 3017491419 · FEI: 3017491419 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ARBOLEAF CORPORATION
    Registration Number
    3017491419
    FEI Number
    3017491419
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    5465 Legacy Drive, Suite 650
    City
    Plano
    State
    TX
    ZIP
    75024
    Country
    US

    Regulatory Submissions

    510(k) Number
    K230176

    Owner / Operator

    Firm Name
    Arboleaf Corporation
    Operator Number
    10078185
    Address
    5465 Legacy Drive, Suite 650
    City
    Plano
    State
    TX
    Postal Code
    75024
    Country
    US
    Correspondent
    Li Zhang

    Products

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

    Proprietary Names

    Arboleaf Upper Arm Blood Pressure Monitor SP10A Arboleaf Upper Arm Blood Pressure Monitor SP20B

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198