BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ACCUTOME, INC.

    Reg #: 2521877 · FEI: 2521877 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    0
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ACCUTOME, INC.
    Registration Number
    2521877
    FEI Number
    2521877
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    3222 Phoenixville Pike
    City
    Malvern
    State
    PA
    ZIP
    19355
    Country
    US

    Regulatory Submissions

    510(k) Number
    K133234

    Owner / Operator

    Firm Name
    ACCUTOME, INC.
    Operator Number
    2521877
    Address
    3222 Phoenixville Pike, --
    City
    Malvern
    State
    PA
    Postal Code
    19355
    Country
    US
    Correspondent
    Claudia Hill

    Products

    Device Name Product Code
    Tonometer, Manual HKY

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198