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FDA 510(k)

MyOnyx System

K-Number: K213197 · 2022-06-17

ApplicantThought Technology , Ltd.
Decision Date2022-06-17
Product CodeIPF
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

MyOnyx System is a medical device manufactured by Thought Technology , Ltd.. It received FDA 510(k) clearance on 2022-06-17 under approval number K213197. The device is classified under product code IPF. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MyOnyx System?

MyOnyx System is a medical device that received FDA 510(k) clearance on 2022-06-17. It is manufactured by Thought Technology , Ltd.. The 510(k) number is K213197.

When was MyOnyx System approved by the FDA?

MyOnyx System received FDA 510(k) clearance on 2022-06-17, under approval number K213197.

What company makes MyOnyx System?

MyOnyx System is manufactured by Thought Technology , Ltd..

What is the FDA product code for MyOnyx System?

The FDA product code for MyOnyx System is IPF.

Other Devices by Thought Technology , Ltd.

K201014MyOnyx 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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