BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Pure Comfort Tempa Check Infrared Thermometer

    Reg #: 3005750815 · FEI: 3008474962 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    HOME AIDE DIAGNOSTICS, INC.
    Registration Number
    3005750815
    FEI Number
    3008474962
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    1072 S Powerline Rd
    City
    Deerfield Bch
    State
    FL
    ZIP
    33442
    Country
    US

    Regulatory Submissions

    510(k) Number
    K181239

    Owner / Operator

    Firm Name
    HOME AIDE DIAGNOSTICS, INC.
    Operator Number
    9087599
    Address
    1072 S. Powerline Rd., --
    City
    Deerfield Bch
    State
    FL
    Postal Code
    33442
    Country
    US
    Correspondent
    AMGAD - GIRGIS

    Products

    Device Name Product Code
    Continuous Measurement Thermometer FLL

    Proprietary Names

    Pure Comfort Tempa Check Infrared Thermometer

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198