BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    EMG CTA01-XXX SERIES PURO OXYGEN CONCENTRATOR

    K Number: K043520 · Decision Oct 21, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    83
    Registration Numbers
    83
    Same Product Code
    286
    Applicant Total
    11
    Review Days
    305

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    Basic Information

    Device Name
    EMG CTA01-XXX SERIES PURO OXYGEN CONCENTRATOR
    K Number
    K043520
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    868.5440
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Emg Technology Co., Ltd.
    Date Received
    December 20, 2004
    Decision Date
    October 21, 2005
    Product Code
    CAW
    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
    CAW Generator, Oxygen, Portable

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