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FDA 510(k)

HealthChek Network Health Station

K-Number: K152107 · 2016-04-12

ApplicantHealthchek Network, LLC
Decision Date2016-04-12
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HealthChek Network Health Station is a medical device manufactured by Healthchek Network, LLC. It received FDA 510(k) clearance on 2016-04-12 under approval number K152107. The device is classified under product code DXN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HealthChek Network Health Station?

HealthChek Network Health Station is a medical device that received FDA 510(k) clearance on 2016-04-12. It is manufactured by Healthchek Network, LLC. The 510(k) number is K152107.

When was HealthChek Network Health Station approved by the FDA?

HealthChek Network Health Station received FDA 510(k) clearance on 2016-04-12, under approval number K152107.

What company makes HealthChek Network Health Station?

HealthChek Network Health Station is manufactured by Healthchek Network, LLC.

What is the FDA product code for HealthChek Network Health Station?

The FDA product code for HealthChek Network Health Station is DXN.

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Related PubMed Literature

PMID: 41730195 Explaining the Slow Adoption of AI Innovations in Health Care: Network Analysis Approach. JMIR AI (2026) PMID: 40830696 A Regulatory Perspective on a UK Federated Data Network for Medicines and Medical Devices: Lessons from a 'Study-A-Thon'. Therapeutic innovation & regulatory science (2026)

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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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