Definition: The Device Is Intended To Measure Abnormal Breath Sound, Such As Wheeze, Rhonchi, And Whistling.
| Device Type ID | 198 |
| Device Name | Abnormal Breath Sound Device |
| Physical State | An Electronic Device |
| Technical Method | It Is A Hand-held Electronic Measurement Device That Utilizes An Acoustic Sensor To Acquire, Amplify, Filter, Record And Analyze Pulmonary Sounds From The Trachea For The Presence Of Breath Sounds Such As Wheeze. |
| Target Area | Trachea |
| Regulation Description | Diagnostic Pulmonary-function Interpretation Calculator. |
| 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 | 868.1900 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PHZ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 198 |
| Device | Abnormal Breath Sound Device |
| Product Code | PHZ |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Diagnostic Pulmonary-function Interpretation Calculator. |
| CFR Regulation Number | 868.1900 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ISONEA LTD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |