| Device |
impedance measuring device utilizing oscillation techniques |
| Regulation Description |
Diagnostic spirometer. |
| Definition |
This device measures respiratory impedance. |
| Physical State |
Device could include a loudspeaker or other means to generate pressure oscillatory signals. The system could also include a bias flow. |
| Technical Method |
Device applies pressure oscillatory signals at the patient’s mouth during spontaneous breathing and measures the response of the respiratory system in terms of impedance, which is the complex ratio between the recorded mouth pressure and the airflow. The frequency of the test signal varies. The device is not intended to be used as a standalone diagnostic device. |
| Target Area |
Lung and airways. |
| Regulation Medical Specialty |
Anesthesiology |
| Review Panel |
Anesthesiology |
|---|
| Product Code | PNV |
|---|
| 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 |
868.1840
|
|---|
| 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 |
