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

    HRI 6500, 6600 AND 6700 SERIES V2MASKS

    K Number: K071149 · Decision Feb 1, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    118
    Registration Numbers
    118
    Same Product Code
    459
    Applicant Total
    11
    Review Days
    283

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    Basic Information

    Device Name
    HRI 6500, 6600 AND 6700 SERIES V2MASKS
    K Number
    K071149
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5905
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Hans Rudolph, Inc.
    Date Received
    April 24, 2007
    Decision Date
    February 1, 2008
    Product Code
    BZD
    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
    BZD Ventilator, Non-Continuous (Respirator)

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