BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Sempulse Halo Vital Signs Monitor

    Reg #: 3019381130 · FEI: 3019381130 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    EMS SOLUTIONS
    Registration Number
    3019381130
    FEI Number
    3019381130
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2520 N 1500 W, Suite A
    City
    Ogden
    State
    UT
    ZIP
    84404
    Country
    US

    Regulatory Submissions

    510(k) Number
    K232495

    Owner / Operator

    Firm Name
    EMS Solutions
    Operator Number
    10081657
    Address
    2520 N 1500 W, Suite A
    City
    Ogden
    State
    UT
    Postal Code
    84404
    Country
    US
    Correspondent
    Jeff Gardner

    Products

    Device Name Product Code
    Continuous Measurement Thermometer FLL
    Oximeter, Ear DPZ
    Oximeter DQA

    Proprietary Names

    Sempulse Halo Vital Signs Monitor

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)