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FDA 510(k)

Current Health System

K-Number: K231506 · 2023-08-24

ApplicantCurrent Health , Ltd.
Decision Date2023-08-24
Product CodeMSX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Current Health System is a medical device manufactured by Current Health , Ltd.. It received FDA 510(k) clearance on 2023-08-24 under approval number K231506. The device is classified under product code MSX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Current Health System?

Current Health System is a medical device that received FDA 510(k) clearance on 2023-08-24. It is manufactured by Current Health , Ltd.. The 510(k) number is K231506.

When was Current Health System approved by the FDA?

Current Health System received FDA 510(k) clearance on 2023-08-24, under approval number K231506.

What company makes Current Health System?

Current Health System is manufactured by Current Health , Ltd..

What is the FDA product code for Current Health System?

The FDA product code for Current Health System is MSX.

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Related PubMed Literature

PMID: 41887630 Capacity building for ethical use of artificial intelligence in health: protocol for a scoping review of training initiatives and gaps in Africa. BMJ open (2026) PMID: 41879133 Medical Device Regulation - Who Does the FDA Serve? The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics (2026) PMID: 41734979 Strategies to Increase Patients' Adherence to Digital Therapeutics for Musculoskeletal Diseases: A Narrative Review. Yonsei medical journal (2026) PMID: 41608759 Collaborative and Cooperative Hospital "In-House" Medical Device Development and Implementation in the AI Age: The European Responsible AI Development (EURAID) Framework Compatible With European Values. Journal of medical Internet research (2026)

Other Devices by Current Health , Ltd.

K191272Wearable Device, Wearable Package K190073Wearable Device, Home Package in Carry Case with Homehub, Home Package in Carry Case without Homehub K222550Current Health System

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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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