BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ActiGraph LEAP

    Reg #: 3028018476 · FEI: 3028018476 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ICON Clinical Research - PRR
    Registration Number
    3028018476
    FEI Number
    3028018476
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    731 Arbor Way, Suite 100
    City
    Blue Bell
    State
    PA
    ZIP
    19422
    Country
    US

    Regulatory Submissions

    510(k) Number
    K231532

    Owner / Operator

    Firm Name
    ICON Clinical Research
    Operator Number
    10090895
    Address
    731 Arbor Way, Suite 100
    City
    Blue Bell
    State
    PA
    Postal Code
    19422
    Country
    US
    Correspondent
    Jamie Harris

    Products

    Device Name Product Code
    Device, Sleep Assessment LEL

    Proprietary Names

    ActiGraph LEAP

    Establishment Types

    Repack or Relabel Medical Device