Devices · FaceHeart Corp.

FaceHeart Vitals Software Development Kit (FH vitals SDK)

FaceHeart Corp. is listed for FaceHeart Vitals Software Development Kit (FH vitals SDK) (K223622). The FDA list gives September 1, 2023 as the date of the final decision. The lead panel is Cardiovascular, and the database link on the FDA list is the 510(k) pathway. openFDA describes product code QME as “Software For Optical Camera-Based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/Or Respiratory Rate”: The device uses software algorithms to analyze video signal and estimate pulse rate, heart rate, respiratory rate and/or breathing rates. This device is not intended to independently direct therapy. openFDA records this submission’s decision description as “Substantially Equivalent.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K223622

Official FDA database record

Date of final decision

September 1, 2023

Company on the FDA list

FaceHeart Corp.

Lead panel

Cardiovascular

Primary product code

QME

openFDA device name for the code

Software For Optical Camera-Based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/Or Respiratory Rate

Device class

2

Regulation number

870.2785

openFDA decision description

Substantially Equivalent

openFDA decision code

SESE

Statement or summary label

Summary