BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Wireless EEG System

    Reg #: 3024892936 · FEI: 3024892936 · Expires 2025
    View on FDA
    Products
    4
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    4

    Registration Details

    Registration Name
    PASCALL SYSTEMS INC
    Registration Number
    3024892936
    FEI Number
    3024892936
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    200 Portland St.
    City
    Boston
    State
    MA
    ZIP
    02114
    Country
    US

    Regulatory Submissions

    510(k) Number
    K213299

    Owner / Operator

    Firm Name
    Pascall Systems Inc
    Operator Number
    10086400
    Address
    200 Portland St.
    City
    Boston
    State
    MA
    Postal Code
    02114
    Country
    US
    Correspondent
    Tuan Le Mau

    Products

    Device Name Product Code
    Electrode, Cutaneous GXY
    Reduced- Montage Standard Electroencephalograph OMC
    Burst Suppression Detection Software For Electroencephalograph ORT
    Non-Normalizing Quantitative Electroencephalograph Software OLT

    Proprietary Names

    Wireless EEG System

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device