BEUDAMED
    Product Code: KHA FDA class 1 21 CFR 868.5590

    Mask, Scavenging

    Anesthesiology

    Scavenging Mask is an anesthesiology device placed over the patient's nose and mouth that captures exhaled anesthetic gases and waste gas vapors, routing them to a scavenging system to prevent occupational exposure of operating room personnel to anesthetic agents. It is classified as FDA Class 1, the lowest risk category, subject to general controls only, meaning it does not require premarket notification or approval. The product code is KHA, regulated under 21 CFR 868.5590, within the Anesthesiology medical specialty.

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    510(k)s
    1
    FEI Numbers
    231
    Registration Numbers
    231
    Unique Applicants
    1
    Years Active
    —

    Basic Information

    Product Code
    KHA
    Device Class
    FDA class 1
    Regulation Number
    868.5590
    Medical Specialty
    Anesthesiology
    Review Panel
    AN
    Submission Type
    4

    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
    K970046 UNIVERSAL LOW PROFILE NASAL HOODS(1250,1275,1350,1450,1475,1550)

    FEI Numbers

    This FDA classification entry is associated with 231 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 231 registration numbers. Click on an entry to view related FDA registrations.