Definition: Pulse Oximeter Intended For Wellness Use.
| Device Type ID | 214 |
| Device Name | Oximeter, Wellness |
| Physical State | Used To Transmit Light At Known Wavelengths(s) Through Blood Using A Light Emitting Diode(s) And Sensor. |
| Technical Method | Transmit Light At A Known Wavelength(s) Through Blood To Measure Photoplethysmographic Data Based On The Amount Of Reflected Or Scattered Light. |
| Target Area | Circulatory Pulse |
| Regulation Description | 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 | Enforcement Discretion |
| CFR Regulation Number | 870.2700 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PGJ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 214 |
| Device | Oximeter, Wellness |
| Product Code | PGJ |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Oximeter. |
| CFR Regulation Number | 870.2700 [🔎] |