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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 the device name listed in this FDA 510(k) record. The listed applicant is Healthchek Network, LLC. It received FDA 510(k) clearance on 2016-04-12 under 510(k) 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. The listed applicant is Healthchek Network, LLC. The 510(k) number is K152107.

When did HealthChek Network Health Station receive FDA 510(k) clearance?

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

Who is the listed applicant for HealthChek Network Health Station?

The FDA 510(k) record lists Healthchek Network, LLC as the applicant. This does not by itself establish the device manufacturer.

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

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

Related Devices (Code: DXN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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

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