BEUDAMED
    FDA Registration Active 🇺🇸 United States

    BioButton MPU

    Reg #: 3016592682 · FEI: 3016592682 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    6
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    BIOINTELLISENSE INC.
    Registration Number
    3016592682
    FEI Number
    3016592682
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    570 El Camino Real, Suite 200
    City
    Redwood City
    State
    CA
    ZIP
    94063
    Country
    US

    Regulatory Submissions

    510(k) Number
    K241101

    Owner / Operator

    Firm Name
    BioIntelliSense Inc.
    Operator Number
    10062701
    Address
    570 El Camino Real, Suite 200
    City
    Redwood City
    State
    CA
    Postal Code
    94063
    Country
    US
    Correspondent
    Yusi Liu

    Products

    Device Name Product Code
    Transmitters And Receivers, Physiological Signal, Radiofrequency DRG
    Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) DRT

    Proprietary Names

    BioButton MPU BioButton System (Multi-patient Use or MPU) BioButton Rechargeable BioButton Rechargeable (BBR) BioButton Charging Station BioButton v3

    Establishment Types

    Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility