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

QME · Class II — Moderate Risk (510(k) clearance required) · Cardiovascular · 21 CFR 870.2785

Classification

FDA Product Code: QME
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 870.2785
Review panel: CV
Medical specialty: Cardiovascular
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

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.

Market data

Cleared 510(k) submissions: 10
Registered establishments: 5

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown