| Device Type ID | 157 |
| Device Name | Device, Positive Pressure Breathing, Intermittent |
| Regulation Description | Noncontinuous Ventilator (IPPB). |
| 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 | 868.5905 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | NHJ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 157 |
| Device | Device, Positive Pressure Breathing, Intermittent |
| Product Code | NHJ |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Noncontinuous Ventilator (IPPB). |
| CFR Regulation Number | 868.5905 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
DIMA ITALIA SRL | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
HILL-ROM SERVICES PTE LTD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
LUNG ASSIST, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Power Cord | 1 |
Air Leak | 1 |
Inadequate Or Insufficient Training | 1 |
Device Operates Differently Than Expected | 1 |
Adverse Event Without Identified Device Or Use Problem | 1 |
| Total Device Problems | 5 |