| 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 Code | NVP |
|---|
| Premarket Review |
Division of Anesthesia, Respiratory, and Sleep Devices
(DHT1C)
Division of Anesthesia, Respiratory, and Sleep 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
Reporting |
Eligible |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Third Party Review |
Not Third Party Eligible |
