Definition: Same As The Identification For Product Code FLS, Just Add Home Use
| Device Type ID | 167 |
| Device Name | Monitor, Apnea, Home 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 | NPF |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | Yes |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 167 |
| Device | Monitor, Apnea, Home Use |
| Product Code | NPF |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Apnea Monitor. |
| CFR Regulation Number | 868.2377 [🔎] |
| Device Problems | |
|---|---|
Device Dislodged Or Dislocated | 20 |
Loose Or Intermittent Connection | 2 |
Solder Joint Fracture | 1 |
Communication Or Transmission Problem | 1 |
| Total Device Problems | 24 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Childrens Medical Ventures | II | Jun-13-2014 |