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FDA 510(k)

Brainomix 360 e-ASPECTS

K-Number: K243294 · 2025-02-14

ApplicantBrainomix Limited
Decision Date2025-02-14
Product CodePOK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Brainomix 360 e-ASPECTS is a medical device manufactured by Brainomix Limited. It received FDA 510(k) clearance on 2025-02-14 under approval number K243294. The device is classified under product code POK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Brainomix 360 e-ASPECTS?

Brainomix 360 e-ASPECTS is a medical device that received FDA 510(k) clearance on 2025-02-14. It is manufactured by Brainomix Limited. The 510(k) number is K243294.

When was Brainomix 360 e-ASPECTS approved by the FDA?

Brainomix 360 e-ASPECTS received FDA 510(k) clearance on 2025-02-14, under approval number K243294.

What company makes Brainomix 360 e-ASPECTS?

Brainomix 360 e-ASPECTS is manufactured by Brainomix Limited.

What is the FDA product code for Brainomix 360 e-ASPECTS?

The FDA product code for Brainomix 360 e-ASPECTS is POK.

Other Devices by Brainomix Limited

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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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