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

    RAC 2A MODULE HOUSING

    K Number: K973984 · Decision Jan 16, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    217
    Registration Numbers
    217
    Same Product Code
    304
    Applicant Total
    9
    Review Days
    88

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    Basic Information

    Device Name
    RAC 2A MODULE HOUSING
    K Number
    K973984
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.1400
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Marquette Medical Systems, Inc.
    Date Received
    October 20, 1997
    Decision Date
    January 16, 1998
    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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