Definition: This Device Measures Respiratory Impedance.
| Device Type ID | 200 |
| Device Name | Impedance Measuring Device Utilizing Oscillation Techniques |
| 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. |
| Target Area | Lung And Airways. |
| Regulation Description | Diagnostic Spirometer. |
| Regulation Medical Specialty | Anesthesiology |
| Review Panel | Anesthesiology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID) Respiratory Devices Branch (RPDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 868.1840 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PNV |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 200 |
| Device | Impedance Measuring Device Utilizing Oscillation Techniques |
| Product Code | PNV |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Diagnostic Spirometer. |
| CFR Regulation Number | 868.1840 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
MEDICAL GRAPHICS CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |