QEM · Cerebral Oximeter
Cardiovascular · 21 CFR 870.2700 · Class 2
Overview
| Product Code | QEM |
|---|---|
| Device Name | Cerebral Oximeter |
| Regulation | 21 CFR 870.2700 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
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.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K182242 | VO200 NeurOs Cerebral Oximetry System | Mespere Lifesciences, Inc. | Dec 26, 2018 | SESE |
Top Applicants
- Mespere Lifesciences, Inc. — 1 clearance
