MyOnyx System
K-Number: K213197 · 2022-06-17
Device Summary
Frequently Asked Questions
What is the MyOnyx System?
MyOnyx System is a medical device that received FDA 510(k) clearance on 2022-06-17. The listed applicant is Thought Technology , Ltd.. The 510(k) number is K213197.
When did MyOnyx System receive FDA 510(k) clearance?
MyOnyx System received FDA 510(k) clearance on 2022-06-17, under 510(k) number K213197.
Who is the listed applicant for MyOnyx System?
The FDA 510(k) record lists Thought Technology , Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for MyOnyx System?
The FDA product code for MyOnyx System is IPF.
Other records listing Thought Technology , Ltd. 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.
Related Devices (Code: IPF)
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.
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.