BEUDAMED
    Product Code: MRQ FDA class 2 21 CFR 868.2385

    Analyzer, Nitrogen Dioxide

    Anesthesiology

    The Nitrogen Dioxide Analyzer is an anesthesiology device used to monitor the concentration of nitrogen dioxide (a toxic byproduct) in respiratory gas mixtures during inhaled nitric oxide therapy, alerting clinicians to potentially harmful levels and ensuring patient safety. Classified as FDA Class 2 under 21 CFR 868.2385, it requires 510(k) premarket notification. The product code is MRQ, and it carries both life-sustaining support and third-party review flags.

    View on FDA
    510(k)s
    0
    FEI Numbers
    6
    Registration Numbers
    6
    Unique Applicants
    0
    Years Active
    —

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    Basic Information

    Product Code
    MRQ
    Device Class
    FDA class 2
    Regulation Number
    868.2385
    Medical Specialty
    Anesthesiology
    Review Panel
    AN
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✓
    Life Sustain/Support
    ✓
    Third Party
    —
    Summary Malfunction Reporting

    FEI Numbers

    This FDA classification entry is associated with 6 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 6 registration numbers. Click on an entry to view related FDA registrations.