BEUDAMED
    FDA Registration Active 🇺🇸 United States

    TOMi Scope

    Reg #: 3016597890 · FEI: 3016597890 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    PHOTONICARE INC
    Registration Number
    3016597890
    FEI Number
    3016597890
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2800 Meridian Pkwy Ste 175
    City
    Durham
    State
    NC
    ZIP
    27713
    Country
    US

    Regulatory Submissions

    510(k) Number
    K191804

    Owner / Operator

    Firm Name
    PhotoniCare Inc
    Operator Number
    10062812
    Address
    2800 Meridian Parkway STE 175
    City
    Durham
    State
    NC
    Postal Code
    27713
    Country
    US
    Correspondent
    Ryan Shelton

    Products

    Device Name Product Code
    Device System, Imaging, Tympanic Membrane And Middle Ear QJG

    Proprietary Names

    TOMi Scope OtoSight Middle Ear Scope

    Establishment Types

    Remanufacture Medical Device Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198