BEUDAMED
    FDA Registration Active 🇮🇸 Iceland

    Nox A1 System

    Reg #: 3007389703 · FEI: 3007389703 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    18
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    NOX MEDICAL
    Registration Number
    3007389703
    FEI Number
    3007389703
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Katrinartuni 2
    City
    Reykjavik
    Country
    IS

    Regulatory Submissions

    510(k) Number
    K192469

    Owner / Operator

    Firm Name
    Nox Medical
    Operator Number
    10027652
    Address
    Katrinartuni 2
    City
    Reykjavik
    State
    IS-55
    Postal Code
    IS-105
    Country
    IS
    Correspondent
    Robert Magnusson

    US Agent

    Business Name
    Nox Health
    Contact Name
    Sigurjon Kristjansson
    Address
    100 Kimball Place, Suite 100
    City
    Alpharetta
    State
    GA
    ZIP
    30009
    Country
    US
    Email
    [email protected]
    Phone
    888 5050280

    Products

    Device Name Product Code
    Device, Muscle Monitoring KZM
    Automatic Event Detection Software For Polysomnograph With Electroencephalograph OLZ

    Proprietary Names

    Nox A1 System Noxturnal US Noxturnal US CD Nox A1 Recorder Nox A1 EEG Head Cable Nox A1 EEG 5 Lead Gold Electrode Cable Nox C1 Kit Nox A1s System Noxturnal PSG Nox A1 Carry Case Noxturnal PSG CD Nox A1 Starter Sensor Kit, Adult Nox C1 Access Point Noxturnal App Nox A1 Starter Sensor Kit, Pediatric Nox C1s Kit Nox A1s Recorder Noxturnal US App

    Establishment Types

    Manufacture Medical Device