FLEXI-SITE (E203-01)/ FLEXI-FIT (E300)
Device Facts
| Record ID | K964055 |
|---|---|
| Device Name | FLEXI-SITE (E203-01)/ FLEXI-FIT (E300) |
| Applicant | Epic Medical Equipment Services, Inc. |
| Product Code | DQA · Cardiovascular |
| Decision Date | Feb 21, 1997 |
| 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.
