Cerebral Oximeter
Device Code: 3635
Product Code(s):
QEM Definition: Oximeter To Measure Cerebral Tissue Saturation
Device Classification Information
| Device Type ID | 3635 |
| Device Name | Cerebral Oximeter |
| Physical State | Light Radiation Transmitter And Receiver With Associated Analytical Hardware And Software To Process The Signal |
| Technical Method | Transmits Light Radiation At Known Wavelength(s) Through Blood To Measure Oxygen Saturation Based On The Amount Of Reflected Or Scattered Radiation |
| Target Area | Head, Skull, Brain |
| Regulation Description | Oximeter. |
| Regulation Medical Specialty | Cardiovascular |
| Review Panel | Neurology |
| Submission Type | 510(k) |
| CFR Regulation Number | 870.2700 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | QEM |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
Recognized Standards
Total Product Life Cycle
| Device Type ID | 3635 |
| Device | Cerebral Oximeter |
| Product Code | QEM |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Oximeter. |
| CFR Regulation Number | 870.2700 [🔎] |
TPLC Last Update: 2019-04-02 20:33:35