BEUDAMED
    Product Code: JFE FDA class 1 21 CFR 868.1965

    Valve, Switching (Ploss)

    Anesthesiology

    A Switching Valve (Ploss) is an anesthesiology accessory used within breathing circuits to direct or switch the flow of respiratory gases between different circuit components or patient positions during anesthesia delivery. It is classified as FDA Class 1 (lowest risk), subject to general controls. The product code is JFE, regulated under 21 CFR 868.1965, within the Anesthesiology medical specialty. This device is exempt from Good Manufacturing Practice (GMP) regulations.

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    510(k)s
    0
    FEI Numbers
    3
    Registration Numbers
    3
    Unique Applicants
    0
    Years Active
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    Basic Information

    Product Code
    JFE
    Device Class
    FDA class 1
    Regulation Number
    868.1965
    Medical Specialty
    Anesthesiology
    Review Panel
    AN
    Submission Type
    4

    Device Characteristics

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

    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.