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

    MODIFICATION TO NICO WITH MARS, MODEL 7300

    K Number: K041450 · Decision Jun 18, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    217
    Registration Numbers
    217
    Same Product Code
    304
    Applicant Total
    7
    Review Days
    17

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    Basic Information

    Device Name
    MODIFICATION TO NICO WITH MARS, MODEL 7300
    K Number
    K041450
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    868.1400
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Respironics Novametrix, Inc.
    Date Received
    June 1, 2004
    Decision Date
    June 18, 2004
    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 Respironics Novametrix, Inc.

    K Number Device Name
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    K032755 MODEL 509M PULSE OXIMETER, MODEL 509M
    K030886 NICO WITH MARS, MODEL 7300