BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Otsuka Digital Feedback Device

    Reg #: 3010742884 · FEI: 3010742884 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Otsuka America Pharmaceutical, Inc
    Registration Number
    3010742884
    FEI Number
    3010742884
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    3956 Point Eden Way
    City
    Hayward
    State
    CA
    ZIP
    94545
    Country
    US

    Regulatory Submissions

    510(k) Number
    K251088

    Owner / Operator

    Firm Name
    OTSUKA AMERICA PHARMACEUTICAL INC
    Operator Number
    9107159
    Address
    2440 RESEARCH BLVD., --
    City
    Rockville
    State
    MD
    Postal Code
    20850
    Country
    US
    Correspondent
    Michael Fahmy

    Products

    Device Name Product Code
    Ingestible Event Marker OZW
    Transmitters And Receivers, Electrocardiograph, Telephone DXH

    Proprietary Names

    Otsuka Digital Feedback Device

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility