> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Zynex Files 510(k) for CO-Oximeter Device
- URL: https://www.fdaweb.com/zynex-files-510-k-for-co-oximeter-device/
- Published: 2025-05-21T12:00:00.000Z
- Updated: 2026-09-14T15:12:22.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5159226

Zynex has submitted a 510(k) for its NiCO, Noninvasive CO-Oximeter device which the company says was designed to address problems with current devices on the market that have been scrutinized for their inaccuracy and limitations. “Zynex's laser technology enables oxygen levels to be measured accurately for patients with dark skin,” it says. “In cases of carbon monoxide (CO) poisoning, not only are the measurements non-invasive and results instantaneous, but both oxygen and CO are measured accurately, potentially reducing the need for taking blood samples and having to wait for the lab results.”

Zynex says the device’s technology directly measures fractional blood oxygenation levels, rather than the current LED technology which estimates functional oxygen saturation (SpO2), giving clinicians a more accurate overview of the patient's real-time oxygenation status. “Unlike current LED-based pulse oximeters, laser-based pulse oximetry performance is not skewed by pigments such as melanin or nail polish, resulting in highly trustworthy measurements and eliminating harmful pigmentation bias problems,” it says. Additionally, the company says its oximeter measures the level of reduced hemoglobin, as well as dysfunctional hemoglobins, specifically carboxyhemoglobin and methemoglobin.