OCH · Oximeter, Infrared, Sporting, Aviation
Cardiovascular · 21 CFR 870.2700 · Class 2
Overview
| Product Code | OCH |
|---|---|
| Device Name | Oximeter, Infrared, Sporting, Aviation |
| 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 (0 of 0)
No cleared devices on record.
