Definition: This Device Is A Volume Assist Ventilator Intended To Aid Adult Patients With Respiratory Insufficiency. It Is Designed For Patients Who Are Capable Of Spontaneously Breathing A Minimum Tidal Volume Of 3.5cc/kg Of Predicted Body Weight. The Device Is
| Device Type ID | 194 |
| Device Name | Mechanical Ventilator |
| Physical State | A Small, Wearable Ventilator That Interfaces With Proprietary Nasal And Tracheostomy Patient Interfaces. |
| Technical Method | The Device Consists Of Two Components: A Ventilator And A Patient Interface. The Device Is A Light-weight, Portable, Electronically Timed And Controlled Volume Assist Ventilator. The Device Delivers 100% Oxygen In Volumes Of 50-250ml. The Device Deli |
| Target Area | The Device Delivers Augmented Volumes Of 100% Oxygen Into The Patient's Airway. |
| Regulation Description | Continuous Ventilator. |
| 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 | 868.5895 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | ONZ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 194 |
| Device | Mechanical Ventilator |
| Product Code | ONZ |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Continuous Ventilator. |
| CFR Regulation Number | 868.5895 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
BREATHE TECHNOLOGIES | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
NEW AERA, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |