Company profile

FaceHeart Corp.

FaceHeart Corp. has 1 AI-enabled medical device on the FDA list. The first decision was on September 1, 2023 and the most recent on September 1, 2023 (FaceHeart Vitals Software Development Kit (FH vitals SDK)). Its most common review panel is Cardiovascular (1 device).

1AI devices

2023First decision

2023Latest decision

1Specialties

Timeline

September 1, 2023 · 510(k) K223622FaceHeart Vitals Software Development Kit (FH vitals SDK) · Cardiovascular · QME