FaceHeart Vitals Software Development Kit (FH vitals SDK)— 510(k) K223622

Name: FDA 510(k) clearance K223622
Creator: U.S. Food and Drug Administration
Published: 2023-09-01

Substantially Equivalent

Faceheart Corp.

FDA 510(k) clearance K223622 for FaceHeart Vitals Software Development Kit (FH vitals SDK), Substantially Equivalent on 2023-09-01. Applicant: Faceheart Corp.. Device class: 2.

Clearance details

Applicant: Faceheart Corp.
Product code: Code QME
Device class: Class 2
Regulation: 21 CFR 870.2785
Advisory panel: Cardiovascular
Date received: 2022-12-05
Decision date: 2023-09-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Grand Cayman, KY

Download summary PDF View on FDA.gov ↗

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