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FDA 510(k)

Sonix Health

K-Number: K240645 · 2024-11-27

ApplicantOntact Health Co., Ltd.
Decision Date2024-11-27
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Sonix Health is a medical device manufactured by Ontact Health Co., Ltd.. It received FDA 510(k) clearance on 2024-11-27 under approval number K240645. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Sonix Health?

Sonix Health is a medical device that received FDA 510(k) clearance on 2024-11-27. It is manufactured by Ontact Health Co., Ltd.. The 510(k) number is K240645.

When was Sonix Health approved by the FDA?

Sonix Health received FDA 510(k) clearance on 2024-11-27, under approval number K240645.

What company makes Sonix Health?

Sonix Health is manufactured by Ontact Health Co., Ltd..

What is the FDA product code for Sonix Health?

The FDA product code for Sonix Health is QIH.

Other Devices by Ontact Health Co., Ltd.

K230209Sonix Health

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Official Source

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