Brainomix 360 e-CTP
K-Number: K223555 · 2023-06-01
ApplicantBrainomix Limited
Decision Date2023-06-01
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Brainomix 360 e-CTP is a medical device manufactured by Brainomix Limited. It received FDA 510(k) clearance on 2023-06-01 under approval number K223555. 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-CTP?
Brainomix 360 e-CTP is a medical device that received FDA 510(k) clearance on 2023-06-01. It is manufactured by Brainomix Limited. The 510(k) number is K223555.
When was Brainomix 360 e-CTP approved by the FDA?
Brainomix 360 e-CTP received FDA 510(k) clearance on 2023-06-01, under approval number K223555.
What company makes Brainomix 360 e-CTP?
Brainomix 360 e-CTP is manufactured by Brainomix Limited.
What is the FDA product code for Brainomix 360 e-CTP?
The FDA product code for Brainomix 360 e-CTP 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.