MEDLEY SP02 MODULE, MODEL 8220
Device Facts
| Record ID | K010966 |
|---|---|
| Device Name | MEDLEY SP02 MODULE, MODEL 8220 |
| Applicant | Alaris Medical Systems, Inc. |
| Product Code | DQA · Cardiovascular |
| Decision Date | Jun 8, 2001 |
| 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.
