BEUDAMED
    Product Code: NHO FDA class 2 21 CFR 868.1500

    Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration)

    Anesthesiology

    The Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration) (product code NHO) is an anesthesiology monitoring device that measures the concentration of desflurane anesthetic gas in the gaseous phase during anesthesia delivery, as described in its definition. It is classified as an FDA Class 2 device within the Anesthesiology specialty, requiring 510(k) premarket clearance. No specific regulation number has been assigned to this product code. The device is not flagged as an implant or life-sustaining device.

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    510(k)s
    0
    FEI Numbers
    48
    Registration Numbers
    48
    Unique Applicants
    0
    Years Active
    —

    Basic Information

    Product Code
    NHO
    Device Class
    FDA class 2
    Regulation Number
    868.1500
    Medical Specialty
    Anesthesiology
    Review Panel
    AN
    Submission Type
    1

    Device Characteristics

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

    Definition

    A desflurane gas analyzer is a device intended to measure the concentration of desflurane anesthetic in a gas mixture.

    FEI Numbers

    This FDA classification entry is associated with 48 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 48 registration numbers. Click on an entry to view related FDA registrations.