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FDA 510(k)

STAYHEALTHY HEALTH KIOSK, STAYHEALTHY HEALTHCENTER KIOSK

K-Number: K123539 · 2013-04-22

ApplicantStayhealthy, Inc.
Decision Date2013-04-22
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

STAYHEALTHY HEALTH KIOSK, STAYHEALTHY HEALTHCENTER KIOSK is the device name listed in this FDA 510(k) record. The listed applicant is Stayhealthy, Inc.. It received FDA 510(k) clearance on 2013-04-22 under 510(k) number K123539. 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 STAYHEALTHY HEALTH KIOSK, STAYHEALTHY HEALTHCENTER KIOSK?

STAYHEALTHY HEALTH KIOSK, STAYHEALTHY HEALTHCENTER KIOSK is a medical device that received FDA 510(k) clearance on 2013-04-22. The listed applicant is Stayhealthy, Inc.. The 510(k) number is K123539.

When did STAYHEALTHY HEALTH KIOSK, STAYHEALTHY HEALTHCENTER KIOSK receive FDA 510(k) clearance?

STAYHEALTHY HEALTH KIOSK, STAYHEALTHY HEALTHCENTER KIOSK received FDA 510(k) clearance on 2013-04-22, under 510(k) number K123539.

Who is the listed applicant for STAYHEALTHY HEALTH KIOSK, STAYHEALTHY HEALTHCENTER KIOSK?

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

What is the FDA product code for STAYHEALTHY HEALTH KIOSK, STAYHEALTHY HEALTHCENTER KIOSK?

The FDA product code for STAYHEALTHY HEALTH KIOSK, STAYHEALTHY HEALTHCENTER KIOSK is DXN.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Stayhealthy, Inc. as applicant

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.

K101807STAYHEALTHY BODY COMPOSITION MONITOR-BCMK052522STAYHEALTHY BODY COMPOSITION ANALYZER, MODELS BC1 AND BC2

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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