BEUDAMED
    Product Code: PRK FDA class 2 21 CFR 868.2375

    Device Indicating An Exhalation Event

    Anesthesiology

    The Device Indicating an Exhalation Event is an anesthesiology device that provides a visual indication of each exhalation event, used to monitor breathing patterns in patients receiving ventilation or anesthetic support. It is classified as FDA Class 2 under 21 CFR 868.2375 in the Anesthesiology specialty, requiring 510(k) premarket notification, and is eligible for third-party review. Product code PRK; not an implant and not life-sustaining.

    View on FDA
    510(k)s
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Unique Applicants
    1
    Years Active
    —

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    Basic Information

    Product Code
    PRK
    Device Class
    FDA class 2
    Regulation Number
    868.2375
    Medical Specialty
    Anesthesiology
    Review Panel
    AN
    Submission Type
    1

    Device Characteristics

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

    Definition

    To provide visual indication of each exhalation event

    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
    K161953 ReDe Mask