BEUDAMED
    FDA Registration Active 🇺🇸 United States

    OnTrak

    Reg #: 3010157426 · FEI: 3010157426 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Spacelabs Healthcare Inc.
    Registration Number
    3010157426
    FEI Number
    3010157426
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    35301 SE Center St
    City
    Snoqualmie
    State
    WA
    ZIP
    98065
    Country
    US

    Regulatory Submissions

    510(k) Number
    K141113

    Owner / Operator

    Firm Name
    SPACELABS HEALTHCARE, INC.
    Operator Number
    2022906
    Address
    35301 SE CENTER STREET, --
    City
    Snoqualmie
    State
    WA
    Postal Code
    98065
    Country
    US

    Products

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

    Proprietary Names

    OnTrak Model 90227 Cuff Covers Ambulatory Blood Pressure Cuffs

    Establishment Types

    Manufacture Medical Device