ETG-100 OPTICAL ENCEPHALOGRAPHY SYSTEM
Device Facts
| Record ID | K011320 |
|---|---|
| Device Name | ETG-100 OPTICAL ENCEPHALOGRAPHY SYSTEM |
| Applicant | Hitachi Medical Systems America, Inc. |
| Product Code | DQA · Cardiovascular |
| Decision Date | Aug 9, 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.
