| Device Type ID | 125 |
| Device Name | Monitor, Apnea, Facility Use |
| Regulation Description | Apnea Monitor. |
| 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 | 868.2377 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | FLS |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | Yes |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 125 |
| Device | Monitor, Apnea, Facility Use |
| Product Code | FLS |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Apnea Monitor. |
| CFR Regulation Number | 868.2377 [🔎] |
| Device Problems | |
|---|---|
Device Alarm System | 6 |
Defective Alarm | 3 |
Adverse Event Without Identified Device Or Use Problem | 3 |
No Audible Alarm | 2 |
Solder Joint Fracture | 1 |
Alarm, Audible | 1 |
Monitor | 1 |
| Total Device Problems | 17 |