Pump, Nebulizer, Manual
The manual nebulizer pump is a hand-operated device used to disperse medication in aerosol form for delivery to the ear, nose, or throat, particularly for conditions such as nasal congestion or sinusitis. It is classified as FDA Class 1, the lowest risk category, requiring only general controls. The product code is EPN, regulated under 21 CFR 874.5220 in the Ear, Nose, Throat specialty. This device is GMP exempt, meaning reduced manufacturing quality system requirements apply.
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Basic Information
- Product Code
- EPN
- Device Class
- FDA class 1
- Regulation Number
- 874.5220
- Medical Specialty
- Ear, Nose, Throat
- Review Panel
- EN
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 30 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 30 registration numbers. Click on an entry to view related FDA registrations.