BEUDAMED
    FDA Registration Active 🇮🇱 Israel

    PillCam™ Genius SB System with PillCam Software v9.7

    Reg #: 9710107 · FEI: 3003348376 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    GIVEN IMAGING LTD.
    Registration Number
    9710107
    FEI Number
    3003348376
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2 Hacarmel St., NEW INDUSTRIAL Park, POB 258
    City
    Yoqneam Northern
    Country
    IL

    Regulatory Submissions

    510(k) Number
    K240276

    Owner / Operator

    Firm Name
    GIVEN IMAGING INC.
    Operator Number
    10091555
    Address
    15 HAMPSHIRE STREET
    City
    Mansfield
    State
    MA
    Postal Code
    02048
    Country
    US
    Correspondent
    AVISHAG METZER

    US Agent

    Business Name
    Medtronic, Inc.
    Contact Name
    Tania Pearson
    Address
    710 Medtronic Pkwy
    City
    Minneapolis
    State
    MN
    ZIP
    55432
    Country
    US
    Email
    [email protected]
    Phone
    916 8138456

    Products

    Device Name Product Code
    System, Imaging, Gastrointestinal, Wireless, Capsule NEZ

    Proprietary Names

    PillCam™ Genius SB System with PillCam Software v9.7 PillCam Cloud Reader Software

    Establishment Types

    Manufacture Medical Device