Brainomix 360 e-CTA
K-Number: K192692 · 2020-05-28
ApplicantBrainomix Limited
Decision Date2020-05-28
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Brainomix 360 e-CTA is a medical device manufactured by Brainomix Limited. It received FDA 510(k) clearance on 2020-05-28 under approval number K192692. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Brainomix 360 e-CTA?
Brainomix 360 e-CTA is a medical device that received FDA 510(k) clearance on 2020-05-28. It is manufactured by Brainomix Limited. The 510(k) number is K192692.
When was Brainomix 360 e-CTA approved by the FDA?
Brainomix 360 e-CTA received FDA 510(k) clearance on 2020-05-28, under approval number K192692.
What company makes Brainomix 360 e-CTA?
Brainomix 360 e-CTA is manufactured by Brainomix Limited.
What is the FDA product code for Brainomix 360 e-CTA?
The FDA product code for Brainomix 360 e-CTA is LLZ.
Other Devices by Brainomix Limited
Related Devices (Code: LLZ)
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.