QYU

2 FDA 510(k) clearances · Product code

FDA profile

Official device name

Infant Pulse Rate And Oxygen Saturation Monitor For Over-The-Counter Use

Device class

Class II (moderate risk)

Regulation

21 CFR 870.2705

Medical specialty

Cardiovascular

FDA definition

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).

Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free