AI devices with FDA product code QZW — Over-The-Counter Device To Assess Risk Of Sleep Apnea

Product code QZW (“Over-The-Counter Device To Assess Risk Of Sleep Apnea” in openFDA) covers 2 devices on the FDA AI-enabled list, from 2 companies. Most are reviewed by the Anesthesiology panel (2). The most recent decision was Sleep Apnea Notification Feature (SANF) on September 13, 2024.