Company profile

Samsung Electronics Co., Ltd

Samsung Electronics Co., Ltd has 2 AI-enabled medical devices on the FDA list. The first decision was on May 2, 2023 and the most recent on February 6, 2024 (Sleep Apnea Feature). Its most common review panel is Anesthesiology (1 device).

2AI devices

2023First decision

2024Latest decision

2Specialties

Timeline

February 6, 2024 · De Novo DEN230041Sleep Apnea Feature · Anesthesiology · QZW
May 2, 2023 · 510(k) K230292Samsung ECG Monitor Application with Irregular Heart Rhythm Notification · Cardiovascular · QDA