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FDA 510(k)

MyOnyx System

K-Number: K201014 · 2021-01-13

ApplicantThought Technology , Ltd.
Decision Date2021-01-13
Product CodeKPI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MyOnyx System is a medical device manufactured by Thought Technology , Ltd.. It received FDA 510(k) clearance on 2021-01-13 under approval number K201014. The device is classified under product code KPI. It was reviewed by the GU 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 2021-01-13. It is manufactured by Thought Technology , Ltd.. The 510(k) number is K201014.

When was MyOnyx System approved by the FDA?

MyOnyx System received FDA 510(k) clearance on 2021-01-13, under approval number K201014.

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 KPI.

Other Devices by Thought Technology , Ltd.

K213197MyOnyx 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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