Definition: The Device Is Intended To Assist In Verifying Ett Tube Placement, Assist In Detecting Ett Tube Movement And Obstruction Of The Tube Tip
| Device Type ID | 195 |
| Device Name | Airway Monitoring System |
| Physical State | The Device Is Comprised Of A Small Monitor And A Sterile, Single Use Adapter. |
| Technical Method | The Device Uses Acoustic Reflection Technologyto Generate An Audible Sound Signal From A Speaker And Two Microphones That Receive Acoustic Reflections That Arise From Within The ETT Tube |
| Target Area | The Device Is Placed In-line Between The Ventilator Circuit And The Proximal End Of The Endotracheal Tube Of A Patient Who Is Connected To A Ventilator. |
| Regulation Description | Tracheal Tube. |
| 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) Anesthesiology Devices Branch (ANDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 868.5730 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | OQU |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 195 |
| Device | Airway Monitoring System |
| Product Code | OQU |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Tracheal Tube. |
| CFR Regulation Number | 868.5730 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
SONARMED, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |