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FDA 510(k)

Brainomix 360 Triage ICH

K-Number: K231195 · 2023-07-27

ApplicantBrainomix Limited
Decision Date2023-07-27
Product CodeQAS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Brainomix 360 Triage ICH is a medical device manufactured by Brainomix Limited. It received FDA 510(k) clearance on 2023-07-27 under approval number K231195. 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 ICH?

Brainomix 360 Triage ICH is a medical device that received FDA 510(k) clearance on 2023-07-27. It is manufactured by Brainomix Limited. The 510(k) number is K231195.

When was Brainomix 360 Triage ICH approved by the FDA?

Brainomix 360 Triage ICH received FDA 510(k) clearance on 2023-07-27, under approval number K231195.

What company makes Brainomix 360 Triage ICH?

Brainomix 360 Triage ICH is manufactured by Brainomix Limited.

What is the FDA product code for Brainomix 360 Triage ICH?

The FDA product code for Brainomix 360 Triage ICH is QAS.

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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