Product Classification | 合法醫療器材資訊網

2021年2月19日 — Use of OTC oximeters has increased as a result of the COVID-19 pandemic. These products are sold as either general wellness or sporting/ ... Read More

2013年3月4日 — FDA has developed this guidance document to assist industry in preparing premarket notifications (510(k)s) for pulse oximeters. Read More

2021年2月19日 — Prescription oximeters undergo FDA review and are available only with a prescription. The FDA requires that these pulse oximeters undergo ... Read More

2021年2月19日 — The FDA issued a safety communication in 2021 informing patients and health care providers that although pulse oximetry is useful for estimating ... Read More

Medbery. “Over-the-counter pulse oximeters either sold online or in pharmacies, without a prescription from your doctor, [are] not FDA reviewed and should not be​ ... Read More

FDA, U.S. Food and Drug Administration. U.S. Food & Drug Administration ... Device, oximeter. Regulation Description, Oximeter. Regulation Medical Specialty ... Read More

FDA, U.S. Food and Drug Administration ... oximeter - A2 Pulse Oximeter; A3 Pulse Oximeter; A4 Pulse Oximeter; A5 Pulse Oximeter; CMS50-Pro Pulse ... Read More

Results 1 - 48 of 195 — Zacurate Pro Series 500DL Fingertip Pulse Oximeter Blood Oxygen Saturation Monitor with Silicon Cover, Batteries and Lanyard (Royal Black). Read More

FDA Warns of Potential Pulse Oximeter Inaccuracies. By Carolyn Crist. Share on ... Feb. 22, 2021 -- Pulse oximeters, which measure blood oxygen levels, have ... Read More

2021年4月1日 — Oxiline Pulse 7 Pro ... “This pulse oximeter is FDA approved, and features great nanosensors with high-level detection,” according to Chen. “Both ... Read More