| Device |
spacer, direct patient interface |
| Regulation Description |
Nebulizer. |
| Definition |
Spacers are devices that are used with nebulizers and metered dose inhalers that are comprised of a reservior into which an aerosol medication is dispensed. A spacer uses an open mouthpiece. Spacers are intended to minimize delivery of large aerosolized particles. |
| Physical State |
Spacers are frequently made of plastic, and can be tube shapped. |
| Technical Method |
By holding drugs after aerosolization, spacers are intended to minimize delivery of large aerosolized particles, which would otherwise deposit in the mouth. |
| Target Area |
Spacers contact the mouth. The drug they are holding is intended for the lower airways |
| Regulation Medical Specialty |
Anesthesiology |
| Review Panel |
Anesthesiology |
|---|
| Product Code | NVO |
|---|
| Premarket Review |
Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices
(OHT1)
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
|
|---|
| Recognized Consensus Standard
|
| Guidance Document
|
| Third Party Review |
Not Third Party Eligible |
