BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SKOUT™ System

    Reg #: 3027395776 · FEI: 3027395776 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    ITERATIVE HEALTH
    Registration Number
    3027395776
    FEI Number
    3027395776
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    14 Arrow Street
    City
    Cambridge
    State
    MA
    ZIP
    02138
    Country
    US

    Regulatory Submissions

    510(k) Number
    K241508

    Owner / Operator

    Firm Name
    Iterative Health
    Operator Number
    10088067
    Address
    14 Arrow Street
    City
    Cambridge
    State
    MA
    Postal Code
    02138
    Country
    US
    Correspondent
    Diane Shay

    Products

    Device Name Product Code
    Gastrointesinal Lesion Software Detection System QNP

    Proprietary Names

    SKOUT™ System

    Establishment Types

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