BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    CAREvent Handheld CPAP System

    Reg #: 9610861 · FEI: 3002807836 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    O-TWO MEDICAL TECHNOLOGIES, INC.
    Registration Number
    9610861
    FEI Number
    3002807836
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    45A Armthorpe Road
    City
    Brampton Ontario
    Country
    CA

    Regulatory Submissions

    510(k) Number
    K093862

    Owner / Operator

    Firm Name
    O-TWO MEDICAL TECHNOLOGIES, INC.
    Operator Number
    8020332
    Address
    45A Armthorpe Road, --
    City
    Brampton
    State
    Ontario
    Postal Code
    L6T 5M4
    Country
    CA

    US Agent

    Business Name
    Pragmatic Compliance dba FDAbasics
    Contact Name
    Jerry Doane
    Address
    15815 SW 11th Court Rd
    City
    Ocala
    State
    FL
    ZIP
    34473
    Country
    US
    Email
    [email protected]
    Phone
    716 7750533

    Products

    Device Name Product Code
    Attachment, Breathing, Positive End Expiratory Pressure BYE
    Ventilator, Emergency, Powered (Resuscitator) BTL

    Proprietary Names

    CAREvent Handheld CPAP System

    Establishment Types

    Manufacture Medical Device