BEUDAMED
    Product Code: JPW FDA class 1 21 CFR 874.5220

    Pump, Nebulizer, Electrically Powered

    Ear, Nose, Throat

    The Pump, Nebulizer, Electrically Powered is an ear, nose, and throat device that uses an electrically driven pump to aerosolize liquid medications into fine particles for inhalation or topical application to nasal and upper airway passages, used in the management of respiratory and ENT conditions. This device is FDA Class 1, the lowest risk category, subject only to general controls with no premarket notification required. It carries product code JPW and is regulated under 21 CFR 874.5220, within the Ear, Nose, and Throat medical specialty. This device is GMP exempt.

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    510(k)s
    1
    FEI Numbers
    33
    Registration Numbers
    33
    Unique Applicants
    1
    Years Active
    —

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    Basic Information

    Product Code
    JPW
    Device Class
    FDA class 1
    Regulation Number
    874.5220
    Medical Specialty
    Ear, Nose, Throat
    Review Panel
    EN
    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
    K833866 ACE/KYLE SELF TAPPING CANNULATED TITA

    FEI Numbers

    This FDA classification entry is associated with 33 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 33 registration numbers. Click on an entry to view related FDA registrations.