BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ISONO HEALTH INC.

    Reg #: 3042585081 · FEI: 3042585081 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    3
    Classifications
    2

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    Registration Details

    Registration Name
    ISONO HEALTH INC.
    Registration Number
    3042585081
    FEI Number
    3042585081
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    538 Oakmead Pkwy
    City
    Sunnyvale
    State
    CA
    ZIP
    94085
    Country
    US

    Regulatory Submissions

    510(k) Number
    K213620

    Owner / Operator

    Firm Name
    iSono Health Inc.
    Operator Number
    10095119
    Address
    538 Oakmead Parkway
    City
    Sunnyvale
    State
    CA
    Postal Code
    94085
    Country
    US
    Correspondent
    Neda Razavi

    Products

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

    Proprietary Names

    ATUSA

    Establishment Types

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