The Nonin Medical TruO2 OTC pulse oximeter and app [Image courtesy of Nonin Medical]Nonin Medical has won FDA 510(k) clearance for its first over-the-counter fingertip pulse oximeter, the TruO2 OTC.

Nonin Medical TruO2 OTC脉搏血氧仪和应用程序[图片由Nonin Medical提供]Nonin Medical凭借其首款非处方指尖脉搏血氧仪TruO2 OTC获得FDA 510（k）许可。

The device will be available for purchase on Amazon.com this month, followed by availability through other online retailers.

该设备将于本月在Amazon.com上购买，随后可通过其他在线零售商购买。

The FDA has warned that pulse oximeters — which beam red and infrared light into a patient’s tissue to measure their blood oxygen saturation and pulse rate — can deliver dangerously inaccurate readings in people with darker skin.

美国食品和药物管理局（FDA）警告称，脉搏血氧仪（向患者组织发射红外光和红外光以测量血氧饱和度和脉搏率）可能会为皮肤较黑的人提供危险的不准确读数。

But Plymouth, Minnesota–based Nonin said the pulse oximetry technology has performed well in independent testing of its professional-use Onyx Vantage 9590, and the new TruO2 OTC device “builds on Nonin‘s legacy of developing durable and accurate pulse oximetry devices.”

但总部位于明尼苏达州普利茅斯的诺宁表示，脉搏血氧仪技术在其专业用途Onyx Vantage 9590的独立测试中表现良好，新型TruO2 OTC设备“建立在诺宁开发耐用准确脉搏血氧仪设备的传统基础上”

“Over the past several years, the U.S. market has been flooded with poor quality, health-and-wellness-grade pulse oximeters which are not regulated by the FDA,” Nonin Medical CEO John Hastings said in a statement shared with MassDevice ahead of the official announcement. “This creates a confusing and frustrating experience for consumers, including those with conditions like COPD or asthma, seeking an accurate, equitable, and durable solution for home use.”.

Nonin Medical首席执行官约翰·黑斯廷斯（JohnHastings）在正式宣布之前与MassDevice分享的一份声明中表示：“过去几年，美国市场充斥着不受FDA监管的低质量、健康和健康级脉搏血氧仪。”。“这给消费者带来了困惑和沮丧的体验，包括那些患有COPD或哮喘等疾病的消费者，他们寻求一种准确，公平和持久的家用解决方案。”。

“The availability of TruO2 OTC now provides all consumers with access to equitable, medical-grade technology that is designed for accuracy across all skin tones,” he continued. “We believe this will significantly enhance the quality and reliability of home-based monitoring, leading to better health outcomes for everyone..

“TruO2 OTC的推出现在为所有消费者提供了公平的医疗级技术，该技术旨在确保所有肤色的准确性，”他继续说道。“我们相信这将大大提高家庭监测的质量和可靠性，从而为每个人带来更好的健康结果。。

In September, Masimo announced its MightySat Medical fingertip pulse oximeter was the first to win FDA clearance for over-the-counter use. That device also performed well in the independent testing cited by Nonin.

9月，Masimo宣布其MightySat Medical fingertip脉搏血氧仪是第一个获得FDA非处方使用许可的仪器。该设备在Nonin引用的独立测试中也表现良好。