Definition: To Assist In Maintaining An Open Airway.
| Device Type ID | 197 |
| Device Name | Oral Airway Assist |
| Physical State | Consists Of Fortiflex B53-35H--1 1, High Density Polyethylene And Is To Be Used With A Latex Strap. |
| Technical Method | To Be Placed In The Mouth And Increase The Pharyngeal Airspace. |
| Target Area | The Oropharyngeal Space. |
| Regulation Description | Oropharyngeal Airway. |
| 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) Exempt |
| CFR Regulation Number | 868.5110 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | PHS |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 197 |
| Device | Oral Airway Assist |
| Product Code | PHS |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Oropharyngeal Airway. |
| CFR Regulation Number | 868.5110 [🔎] |