| Device Type ID | 60 |
| Device Name | Ventilator, External Body, Negative Pressure, Adult (cuirass) |
| Regulation Description | External Negative Pressure 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 | 868.5935 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | BYT |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | Yes |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 60 |
| Device | Ventilator, External Body, Negative Pressure, Adult (cuirass) |
| Product Code | BYT |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | External Negative Pressure Ventilator. |
| CFR Regulation Number | 868.5935 [🔎] |
| Device Problems | |
|---|---|
Insufficient Information | 1 |
Adverse Event Without Identified Device Or Use Problem | 1 |
| Total Device Problems | 2 |