FaceHeart Vitals Software Development Kit (FH vitals SDK-RR)— 510(k) K243966

Name: FDA 510(k) clearance K243966
Creator: U.S. Food and Drug Administration
Published: 2025-04-09

Substantially Equivalent

Faceheart Corp.

FDA 510(k) clearance K243966 for FaceHeart Vitals Software Development Kit (FH vitals SDK-RR), Substantially Equivalent on 2025-04-09. Applicant: Faceheart Corp.. Device class: 2.

Clearance details

Applicant: Faceheart Corp.
Product code: Code BZQ
Device class: Class 2
Regulation: 21 CFR 868.2375
Advisory panel: Anesthesiology
Date received: 2024-12-23
Decision date: 2025-04-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Grand Cayman, KY

Download summary PDF View on FDA.gov ↗

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