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

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..

Clearance details

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

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