Hardware And Software For Optical Camera-Based Measurement Of Heart Rate And Respiratory Rate

QOK · Class II — Moderate Risk (510(k) clearance required) · Cardiovascular · 21 CFR 870.2786

Classification

FDA Product Code: QOK
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 870.2786
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 an optical sensor system and software algorithms to obtain and 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: 1
Registered establishments: 0

Source

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