BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Auto 3D Bladder Volume Tool

    Reg #: 3010102386 · FEI: 3010102386 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    BUTTERFLY NETWORK, INC.
    Registration Number
    3010102386
    FEI Number
    3010102386
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1600 District Ave
    City
    Burlington
    State
    MA
    ZIP
    01803
    Country
    US

    Regulatory Submissions

    510(k) Number
    K200980

    Owner / Operator

    Firm Name
    Butterfly Network, Inc.
    Operator Number
    10057531
    Address
    1600 District Ave
    City
    Burlington
    State
    MA
    Postal Code
    01803
    Country
    US

    Products

    Device Name Product Code
    System, Imaging, Pulsed Echo, Ultrasonic IYO
    Transducer, Ultrasonic, Diagnostic ITX

    Proprietary Names

    Auto 3D Bladder Volume Tool

    Establishment Types

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