BEUDAMED
    Product Code: JEG FDA class 2 21 CFR 868.1075

    Analyzer, Gas, Argon, Gaseous-Phase

    Anesthesiology

    The Gaseous-Phase Argon Gas Analyzer is a device that measures the concentration of argon gas in respiratory or anesthesia gas mixtures, used in pulmonary function testing and anesthetic gas monitoring applications. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket notification and compliance with general and special controls. The product code is JEG, regulated under 21 CFR 868.1075, within the Anesthesiology medical specialty. This device is eligible for third-party review under FDA's 510(k) program.

    View on FDA
    510(k)s
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Unique Applicants
    1
    Years Active
    —

    Basic Information

    Product Code
    JEG
    Device Class
    FDA class 2
    Regulation Number
    868.1075
    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

    Loading...

    Related 510(k) Clearances

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

    K Number Device Name
    K880442 BRUSHRITE

    FEI Numbers

    This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.