Company profile

EarliTec Diagnostics, Inc

EarliTec Diagnostics, Inc has 2 AI-enabled medical devices on the FDA list. The first decision was on June 8, 2022 and the most recent on June 29, 2023 (EarliPoint). Its most common review panel is Neurology (2 devices).

2AI devices

2022First decision

2023Latest decision

1Specialties

Related guides

Top neurology devices

Timeline

June 29, 2023 · 510(k) K230337EarliPoint · Neurology · QPF
June 8, 2022 · 510(k) K213882EarliPoint System · Neurology · QPF