BEUDAMED
    FDA Registration Active 🇺🇸 United States

    DICTUM HEALTH, INC.

    Reg #: 3011359729 · FEI: 3011359729 · Expires 2026
    View on FDA
    Products
    11
    Proprietary Names
    5
    Establishment Types
    2
    Classifications
    11

    Registration Details

    Registration Name
    DICTUM HEALTH, INC.
    Registration Number
    3011359729
    FEI Number
    3011359729
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    32860 Pacific Coast Highway
    City
    Malibu
    State
    CA
    ZIP
    90265
    Country
    US

    Regulatory Submissions

    510(k) Number
    K152645

    Owner / Operator

    Firm Name
    Dictum Health
    Operator Number
    10051189
    Address
    32860 Pacific Coast Highway
    City
    Malibu
    State
    CA
    Postal Code
    90265
    Country
    US

    Products

    Device Name Product Code
    Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) MWI
    Monitor, Bed Patient KMI
    System, Measurement, Blood-Pressure, Non-Invasive DXN
    Electrode, Electrocardiograph DRX
    Electrocardiograph DPS
    Audiometer EWO
    Oximeter DQA
    Spirometer, Diagnostic BZG
    Blood Pressure Cuff DXQ
    Continuous Measurement Thermometer FLL
    Stethoscope, Electronic DQD

    Proprietary Names

    IDM100 eVER-HOME, SpO2 Sensor, Blood Pressure Monitor, Ear Thermometer eVERHome eVER-HOME, SpO2 Sensor, Blood Pressure Monitor, Ear Thermometer, Scale eVER-HOME Tablet

    Establishment Types

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