| Device Type ID | 148 |
| Device Name | Ventilator, Continuous, Non-life-supporting |
| 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 | MNS |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 148 |
| Device | Ventilator, Continuous, Non-life-supporting |
| Product Code | MNS |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Continuous Ventilator. |
| CFR Regulation Number | 868.5895 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
RESMED LTD | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
| Device Problems | |
|---|---|
Device Displays Incorrect Message | 11 |
No Flow | 5 |
No Audible Alarm | 3 |
Failure To Power Up | 3 |
Device Alarm System | 3 |
Insufficient Information | 2 |
Loss Of Power | 2 |
Adverse Event Without Identified Device Or Use Problem | 2 |
Increase In Pressure | 2 |
Device Stops Intermittently | 2 |
Device Operational Issue | 2 |
Fire | 1 |
Device Operates Differently Than Expected | 1 |
Unexpected Therapeutic Results | 1 |
Device Inoperable | 1 |
Blower | 1 |
Capacitor | 1 |
Failure To Pump | 1 |
Decrease In Pressure | 1 |
Pressure Problem | 1 |
Noise, Audible | 1 |
Mechanical Problem | 1 |
No Device Output | 1 |
Overheating Of Device | 1 |
Thermal Decomposition Of Device | 1 |
Free Or Unrestricted Flow | 1 |
Alarm, Audible | 1 |
| Total Device Problems | 53 |