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

    FISIO CHAMBER SPACE

    K Number: K101136 · Decision Jan 28, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    26
    Registration Numbers
    26
    Same Product Code
    15
    Applicant Total
    2
    Review Days
    281

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    Basic Information

    Device Name
    FISIO CHAMBER SPACE
    K Number
    K101136
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5630
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Koo (Shanghai) Industries Co., Ltd.
    Date Received
    April 22, 2010
    Decision Date
    January 28, 2011
    Product Code
    NVP
    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
    NVP Holding Chambers, Direct Patient Interface

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    Other Clearances by Koo (Shanghai) Industries Co., Ltd.

    K Number Device Name
    K112041 KOO SMALL VOLUME NEBULIZER (SVN)