BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Eagle II

    Reg #: 1220908 · FEI: 1220908 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    3
    Establishment Types
    3
    Classifications
    2

    Registration Details

    Registration Name
    ZOLL MEDICAL CORPORATION
    Registration Number
    1220908
    FEI Number
    1220908
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    269 MILL ROAD
    City
    CHELMSFORD
    State
    MA
    ZIP
    01824
    Country
    US

    Regulatory Submissions

    510(k) Number
    K162832

    Owner / Operator

    Firm Name
    ZOLL Medical Corporation
    Operator Number
    1220908
    Address
    269 MILL ROAD
    City
    Chelmsford
    State
    MA
    Postal Code
    01824
    Country
    US
    Correspondent
    Paul Dias

    Products

    Device Name Product Code
    Oximeter DQA
    Ventilator, Continuous, Facility Use CBK

    Proprietary Names

    Eagle II AEV EMV+

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device