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    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    Medical Gas Analyzer (AG200)

    K Number: K250148 · Decision Aug 28, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    217
    Registration Numbers
    217
    Same Product Code
    304
    Applicant Total
    1
    Review Days
    219

    Basic Information

    Device Name
    Medical Gas Analyzer (AG200)
    K Number
    K250148
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.1400
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Prior Care Science Technology, Ltd.
    Date Received
    January 21, 2025
    Decision Date
    August 28, 2025
    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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