BEUDAMED
    Product Code: BTP FDA class 1 21 CFR 868.5420

    Dropper, Ether

    Anesthesiology

    The Dropper, Ether is a simple device used to administer liquid ether by drops onto an open mask or cloth for inhalation anesthesia, representing an early form of anesthetic delivery. It is classified as FDA Class 1, the lowest risk category, subject to general controls only. The product code is BTP, regulated under 21 CFR 868.5420 in the Anesthesiology specialty. This device is exempt from Good Manufacturing Practice (GMP) requirements.

    View on FDA
    510(k)s
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Unique Applicants
    1
    Years Active
    —

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    Basic Information

    Product Code
    BTP
    Device Class
    FDA class 1
    Regulation Number
    868.5420
    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
    K093126 ANAPNOGUARD ENDOTRACHEAL TUBE

    FEI Numbers

    This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.