BEUDAMED
    FDA Registration Active 🇺🇸 United States

    DR300 Holter Recorder, DR400 Holter Patch Recorder

    Reg #: 1224919 · FEI: 1000513706 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    NORTHEAST MONITORING, INC.
    Registration Number
    1224919
    FEI Number
    1000513706
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    141 Parker Street, Suite # 200
    City
    MAYNARD
    State
    MA
    ZIP
    01754
    Country
    US

    Regulatory Submissions

    510(k) Number
    K142424

    Owner / Operator

    Firm Name
    NORTHEAST MONITORING, INC.
    Operator Number
    9021067
    Address
    141 Parker Street, Suite #200
    City
    Maynard
    State
    MA
    Postal Code
    01754
    Country
    US
    Correspondent
    SHERRY L STEELE

    Products

    Device Name Product Code
    Electrocardiograph, Ambulatory (Without Analysis) MWJ

    Proprietary Names

    DR300 Holter Recorder, DR400 Holter Patch Recorder

    Establishment Types

    Manufacture Medical Device