BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    MICROGARD II

    K Number: K111408 · Decision Oct 17, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    141
    Registration Numbers
    141
    Same Product Code
    201
    Applicant Total
    12
    Review Days
    151

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    Basic Information

    Device Name
    MICROGARD II
    K Number
    K111408
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5260
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Carefusion Germany 234 GmbH
    Date Received
    May 19, 2011
    Decision Date
    October 17, 2011
    Product Code
    CAH
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    CAH Filter, Bacterial, Breathing-Circuit

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    K122699 SENTRYSUITE PRODUCT LINE
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