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U.S. Department of Health and Human Services

Product Classification

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Device holding chambers, direct patient interface
Regulation Description Nebulizer.
Definition Holding chambers are devices that are used with nebulizers and metered dose inhalers and are comprised of a reservoir into which an aerosol medication is dispensed. A holding chamber uses a valved mouthpiece through which the patient inhales the dispensed medication. Holding chambers are intended to minimize delivery of large aerosolized particles
Physical State Holding Chambers are frequently made of plastic, and can be tube shaped.
Technical Method By holding drugs after aerosolization, holding chambers are intended to minimize delivery of large aerosolized particles which would otherwise depisit in the mouth, throat, or upper airway
Target Area Holding Chambers contact the mouth. The drug they are holding is intended for the lower airways
Regulation Medical Specialty Anesthesiology
Review Panel Anesthesiology
Product CodeNVP
Premarket Review Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1)
ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices (DHT1C)
Submission Type 510(k)
Regulation Number 868.5630
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible