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 [🔎] |