FDA Product Code QYU: Infant Pulse Rate And Oxygen Saturation Monitor For Over-the-counter Use
An Infant Pulse Rate And Oxygen Saturation Monitor For Over-the-counter Use Is A Device That Uses Photoplethysmography To Measure Pulse Rate And Oxygen Saturation In Infants. The Device May Contain Alarms That Alert The Caregiver When Vital Sign(s) Go Outside Preset Threshold(s).
Leading manufacturers include Masimo Corporation.
List of Infant Pulse Rate And Oxygen Saturation Monitor For Over-the-counter Use devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Infant Pulse Rate And Oxygen Saturation Monitor For Over-the-counter Use devices (product code QYU). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Cardiovascular FDA review panel. Browse all Cardiovascular devices →