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FDA 510(k)

FaceHeart Vitals Software Development Kit (FH vitals SDK)

K-Number: K223622 · 2023-09-01

ApplicantFaceheart Corp.
Decision Date2023-09-01
Product CodeQME
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

FaceHeart Vitals Software Development Kit (FH vitals SDK) is a medical device manufactured by Faceheart Corp.. It received FDA 510(k) clearance on 2023-09-01 under approval number K223622. The device is classified under product code QME. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FaceHeart Vitals Software Development Kit (FH vitals SDK)?

FaceHeart Vitals Software Development Kit (FH vitals SDK) is a medical device that received FDA 510(k) clearance on 2023-09-01. It is manufactured by Faceheart Corp.. The 510(k) number is K223622.

When was FaceHeart Vitals Software Development Kit (FH vitals SDK) approved by the FDA?

FaceHeart Vitals Software Development Kit (FH vitals SDK) received FDA 510(k) clearance on 2023-09-01, under approval number K223622.

What company makes FaceHeart Vitals Software Development Kit (FH vitals SDK)?

FaceHeart Vitals Software Development Kit (FH vitals SDK) is manufactured by Faceheart Corp..

What is the FDA product code for FaceHeart Vitals Software Development Kit (FH vitals SDK)?

The FDA product code for FaceHeart Vitals Software Development Kit (FH vitals SDK) is QME.

Related Clinical Trials

NCT03331380 Technical Development of Cardiovascular Magnetic Resonance Imaging (CMR) Using a Low Specific Absorption Rate (SAR) Scanner System RECRUITING NCT03053141 RHythmia mAPping and Signal acquisitiOn for Data analYsis (RHAPSODY) RECRUITING NCT07557147 Single-arm, Multi-center Study Evaluating the Acceptance and Feasibility of a Digital Remote Monitoring Tool Configured for Patients With ATTR-CM: ACO-Monitor NOT_YET_RECRUITING NCT02091518 Development and Evaluation of Magnetic Resonance Imaging Acquisition and Analysis Methods ENROLLING_BY_INVITATION NCT07084779 Investigation of Impact of AI on Prostate Cancer Workflow RECRUITING NCT01821170 Cognitive Remediation in ADHD Children : Comparison Between Three Therapeutic Strategies : Cognitive Remediation With a Virtual Classroom Software and Methylphenidate and Supportive Psychotherapy COMPLETED

Related PubMed Literature

PMID: 41967377 Governing the rise of AI in healthcare: A comparative governance document and implementation implications across five jurisdictions. Social science & medicine (1982) (2026) PMID: 41967338 Patient-tailored brachytherapy applicator development in compliance with the EU medical device regulation. Physica medica : PM : an international journal devoted to the applications of physics to medicine and biology : official journal of the Italian Association of Biomedical Physics (AIFB) (2026) PMID: 41883556 A clinician's quick‑start guide to implementing digital health innovations in the NHS - with lessons from a UK-deployed AI stroke imaging decision-support software. Digital health (2026) PMID: 41844911 Toward global standards for SaMD: introducing a proposal for Good Digital Medicine Practices (GDMP). NPJ digital medicine (2026)

Other Devices by Faceheart Corp.

K243966FaceHeart Vitals Software Development Kit (FH vitals SDK-RR)

Related Devices (Code: QME)

K211906Vital SignsOxehealth Limited DEN200019Oxehealth Vital SignsOxehealth Limited K220899Oxehealth Vital SignsOxehealth Limited K240890PanopticAI Vital SignsPanopticAI technologies Limited K241633Informed Vital Core Application (IVC App)Mindset Medical, Inc. K232804FibriCheckQompium NV

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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