BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ASSURE Wearable ECG

    Reg #: 3015185344 · FEI: 3015185344 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    KESTRA Medical Technologies, Inc.
    Registration Number
    3015185344
    FEI Number
    3015185344
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    3933 Lake Washington Blvd, NE
    City
    Kirkland
    State
    WA
    ZIP
    98033
    Country
    US

    Regulatory Submissions

    510(k) Number
    K233864

    Owner / Operator

    Firm Name
    Kestra Medical
    Operator Number
    10082485
    Address
    3933 Lake Washington Blvd, NE
    City
    Kirkland
    State
    WA
    Postal Code
    98033
    Country
    US
    Correspondent
    Beverly Magrane

    Products

    Device Name Product Code
    Electrocardiograph, Ambulatory (Without Analysis) MWJ
    Transmitters And Receivers, Electrocardiograph, Telephone DXH

    Proprietary Names

    ASSURE Wearable ECG

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility