| Device Type ID | 208 |
| Device Name | Oximeter, Ear |
| Regulation Description | Ear Oximeter. |
| Regulation Medical Specialty | Cardiovascular |
| Review Panel | Anesthesiology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID) Anesthesiology Devices Branch (ANDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 870.2710 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | DPZ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 208 |
| Device | Oximeter, Ear |
| Product Code | DPZ |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Ear Oximeter. |
| CFR Regulation Number | 870.2710 [🔎] |
| Device Problems | |
|---|---|
Low Readings | 2 |
High Readings | 1 |
Device Displays Incorrect Message | 1 |
Inappropriate Or Unexpected Reset | 1 |
No Audible Alarm | 1 |
Incorrect Measurement | 1 |
Alarm Not Visible | 1 |
| Total Device Problems | 8 |