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

    AS/3 NETWORK LINK

    K Number: K953006 · Decision Sep 27, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    217
    Registration Numbers
    217
    Same Product Code
    304
    Applicant Total
    5
    Review Days
    91

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    Basic Information

    Device Name
    AS/3 NETWORK LINK
    K Number
    K953006
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.1400
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Datex Medical Instrumentation, Inc.
    Date Received
    June 28, 1995
    Decision Date
    September 27, 1995
    Product Code
    CCK
    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
    CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase

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    Other Clearances by Datex Medical Instrumentation, Inc.

    K Number Device Name
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    K912530 CARDIOCAP II(TM)