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

    MICROBLAB, MICROLOOP

    K Number: K141936 · Decision Dec 29, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    92
    Registration Numbers
    92
    Same Product Code
    227
    Applicant Total
    12
    Review Days
    165

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    Basic Information

    Device Name
    MICROBLAB, MICROLOOP
    K Number
    K141936
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.1840
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Carefusion Germany 234 GmbH
    Date Received
    July 17, 2014
    Decision Date
    December 29, 2014
    Product Code
    BZG
    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
    BZG Spirometer, Diagnostic

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    Other Clearances by Carefusion Germany 234 GmbH

    K Number Device Name
    K153654 Sentry WEB SmartInterp
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    K142959 Vyntus Walk
    K133925 VYNTUS/ SENTRYSUITE PRODUCT LINE
    K122699 SENTRYSUITE PRODUCT LINE
    K113813 SENTRYSUITE PRODUCT LINE
    K113096 MICRO I
    K111408 MICROGARD II
    K111053 SENTRYSUITE PRODUCT LINE
    K101873 MASTERSCREEN IOS
    Search all 12 clearances from Carefusion Germany 234 GmbH →