TRUSIGNAL SPO2 FINGERTIP SENSOR
Device Facts
| Record ID | K101871 |
|---|---|
| Device Name | TRUSIGNAL SPO2 FINGERTIP SENSOR |
| Applicant | GE Healthcare Finland Oy |
| Product Code | DQA · Cardiovascular |
| Decision Date | Oct 4, 2010 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.2700 |
| Device Class | Class 2 |
Regulatory Classification
Identification
An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.
