BEUDAMED
    FDA Registration Active 🇮🇱 Israel

    Nelcore Adult SpO2 sensor and Pulse Oximetry Interface Cable

    Reg #: 3005004021 · FEI: 3005004021 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    Baxter Healthcare - Tel Aviv
    Registration Number
    3005004021
    FEI Number
    3005004021
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2A Hashlosha St. F-32
    City
    Tel Aviv
    Country
    IL

    Regulatory Submissions

    510(k) Number
    K012891

    Owner / Operator

    Firm Name
    BAXTER HEALTHCARE CORPORATION
    Operator Number
    1417572
    Address
    One Baxter Parkway
    City
    Deerfield
    State
    IL
    Postal Code
    60015
    Country
    US
    Correspondent
    Maha Nolasco

    US Agent

    Business Name
    BAXTER HEALTHCARE CORPORATION
    Contact Name
    Maha Nolasco
    Address
    25212 W. IL Route 120, RLT-04
    City
    Round Lake
    State
    IL
    ZIP
    60073
    Country
    US
    Email
    [email protected]
    Phone
    224 2706181

    Products

    Device Name Product Code
    Oximeter DQA
    Oximeter, Ear DPZ

    Proprietary Names

    Nelcore Adult SpO2 sensor and Pulse Oximetry Interface Cable OXIMAX PULSE OXIMETRY SYSTEM WITH N-595 PULSE OXIMETER AND OXIMAX SENSORS AND CABLES (AKA ACCESSORIES)

    Establishment Types

    Repack or Relabel Medical Device Export Device to the United States But Perform No Other Operation on Device