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

    Sentry WEB SmartInterp

    K Number: K153654 · Decision Sep 16, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    178
    Registration Numbers
    178
    Same Product Code
    429
    Applicant Total
    12
    Review Days
    270

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    Basic Information

    Device Name
    Sentry WEB SmartInterp
    K Number
    K153654
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1425
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Carefusion Germany 234 GmbH
    Date Received
    December 21, 2015
    Decision Date
    September 16, 2016
    Product Code
    DQK
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

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

    Product Code Device Name
    DQK Computer, Diagnostic, Programmable

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    Other Clearances by Carefusion Germany 234 GmbH

    K Number Device Name
    K150810 Vyntus / SentrySuite Product Line
    K142959 Vyntus Walk
    K141936 MICROBLAB, MICROLOOP
    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
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