QYU

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

Product code

QYU

Device name

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

Device class

Class 2

21 CFR

21 CFR 870.2705

Medical specialty

Cardiovascular

Marketing pathway

510(K)

510(k) clearances (last 3 years)

2

Summaries archived here

1 (direct download)

510(k) clearances (all years, FDA)

2 (all years; only the last 3 years are listed here)

FDA classification 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).

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (2)

Last three years. Most recent: 2024-05-03.

1 summaries are archived here for direct download.