BEUDAMED
    FDA Registration Active 🇺🇸 United States

    BioButton™ wearable device

    Reg #: 3017986070 · FEI: 3017986070 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    BIOINTELLISENSE INC.
    Registration Number
    3017986070
    FEI Number
    3017986070
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    17301 W. Colfax Ave., Suite 152
    City
    Golden
    State
    CO
    ZIP
    80401
    Country
    US

    Regulatory Submissions

    510(k) Number
    K212957

    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

    Products

    Device Name Product Code
    Transmitters And Receivers, Physiological Signal, Radiofrequency DRG
    Calculator, Drug Dose NDC

    Proprietary Names

    BioButton™ wearable device BioButton™ wearable sensor BioButton™ BioButton™ remote patient monitoring device

    Establishment Types

    Repack or Relabel Medical Device