BEUDAMED
    FDA Registration Active 🇺🇸 United States

    gammaCore Sapphire SLC

    Reg #: 3015529603 · FEI: 3015529603 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    4
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    ELECTROCORE, INC.
    Registration Number
    3015529603
    FEI Number
    3015529603
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    200 Forge Way, Suite 205
    City
    Rockaway
    State
    NJ
    ZIP
    07866
    Country
    US

    Regulatory Submissions

    510(k) Number
    K211856

    Owner / Operator

    Firm Name
    ElectroCore, Inc.
    Operator Number
    10038007
    Address
    200 Forge Way, Suite 205
    City
    Rockaway
    State
    NJ
    Postal Code
    07866
    Country
    US
    Correspondent
    Steve Smith

    Products

    Device Name Product Code
    Non-Invasive Vagus Nerve Stimulator For Migraine Headache QAK
    Non-Invasive Vagus Nerve Stimulator - Headache PKR

    Proprietary Names

    gammaCore Sapphire SLC gammaCore Sapphire gammaCore Sapphire D gammaCore Sapphire 3

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198