BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    Medipure Oxygen-LC System

    K Number: K153518 · Decision Jun 3, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15
    Same Product Code
    12
    Applicant Total
    1
    Review Days
    178

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    Medipure Oxygen-LC System
    K Number
    K153518
    Device Class
    FDA class 1
    Clearance Type
    Special
    Regulation Number
    868.2700
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Praxair Distribution, Incorporated.
    Date Received
    December 8, 2015
    Decision Date
    June 3, 2016
    Product Code
    ECX
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    ECX Cylinder, Compressed Gas, And Valve

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (ECX), ordered by most recent decision date.

    Intelli-Ox

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    Walk-O2-Bout

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    Intelli-Ox

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    OXYTOTE INFINITY SERIES VIPR SYSTEMS

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    GRAB 'N GO PLUS, GRAB 'N GO DIGITAL

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    EZ-OX PLUS GENERATION II

    FDA 510(k)
    FDA Class 1 ·Anesthesiology
    View all