BEUDAMED
    Product Code: MRP FDA class 2 21 CFR 868.2380

    Analyzer, Nitric Oxide

    Anesthesiology

    The Nitric Oxide Analyzer is an anesthesiology device used to continuously monitor and measure the concentration of nitric oxide in inspired or expired gas, ensuring accurate delivery and safe levels during inhaled nitric oxide therapy. Classified as FDA Class 2 under 21 CFR 868.2380 in the Anesthesiology specialty, it requires 510(k) premarket notification. The product code is MRP.

    View on FDA
    510(k)s
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Unique Applicants
    1
    Years Active
    —

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    Basic Information

    Product Code
    MRP
    Device Class
    FDA class 2
    Regulation Number
    868.2380
    Medical Specialty
    Anesthesiology
    Review Panel
    AN
    Submission Type
    1

    Device Characteristics

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

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 1 510(k) clearance via K numbers.

    K Number Device Name
    K023014 VIANOX DELIVERY SYSTEM, MODEL I

    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.