QME

Software For Optical Camera-Based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/Or Respiratory Rate

Product code

QME

Device name

Software For Optical Camera-Based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/Or Respiratory Rate

Device class

Class 2

21 CFR

21 CFR 870.2785

Medical specialty

Cardiovascular

Marketing pathway

510(K)

510(k) clearances (last 3 years)

9

Summaries archived here

9 (direct download)

510(k) clearances (all years, FDA)

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

FDA classification definition

The device uses software algorithms to analyze video signal and estimate pulse rate, heart rate, respiratory rate and/or breathing rates. This device is not intended to independently direct therapy.

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

510(k) clearances, last 3 years (9)

Last three years. Most recent: 2026-06-18.

9 summaries are archived here for direct download.