FLEXI-SITE SP02 EAR SENSOR
Device Facts
| Record ID | K010718 |
|---|---|
| Device Name | FLEXI-SITE SP02 EAR SENSOR |
| Applicant | Epic Medical Equipment Services, Inc. |
| Product Code | DPZ · Cardiovascular |
| Decision Date | Mar 23, 2001 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 870.2710 |
| Device Class | Class 2 |
Regulatory Classification
Identification
An ear oximeter is an extravascular device used to transmit light at a known wavelength(s) through blood in the ear. The amount of reflected or scattered light as indicated by this device is used to measure the blood oxygen saturation.
