Brainomix 360 Triage Stroke
K-Number: K232496 · 2023-11-21
ApplicantBrainomix Limited
Decision Date2023-11-21
Product CodeQAS
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Brainomix 360 Triage Stroke is a medical device manufactured by Brainomix Limited. It received FDA 510(k) clearance on 2023-11-21 under approval number K232496. The device is classified under product code QAS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Brainomix 360 Triage Stroke?
Brainomix 360 Triage Stroke is a medical device that received FDA 510(k) clearance on 2023-11-21. It is manufactured by Brainomix Limited. The 510(k) number is K232496.
When was Brainomix 360 Triage Stroke approved by the FDA?
Brainomix 360 Triage Stroke received FDA 510(k) clearance on 2023-11-21, under approval number K232496.
What company makes Brainomix 360 Triage Stroke?
Brainomix 360 Triage Stroke is manufactured by Brainomix Limited.
What is the FDA product code for Brainomix 360 Triage Stroke?
The FDA product code for Brainomix 360 Triage Stroke is QAS.
Other Devices by Brainomix Limited
Related Devices (Code: QAS)
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.