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FDA 510(k)

Brainomix 360 e-ASPECTS

K-Number: K221564 · 2023-02-23

ApplicantBrainomix Limited
Decision Date2023-02-23
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 2023-02-23 under approval number K221564. 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 2023-02-23. It is manufactured by Brainomix Limited. The 510(k) number is K221564.

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

Brainomix 360 e-ASPECTS received FDA 510(k) clearance on 2023-02-23, under approval number K221564.

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

K192692Brainomix 360 e-CTA K232496Brainomix 360 Triage Stroke K231837Brainomix 360 Triage LVO K231656Brainomix 360 e-MRI K231195Brainomix 360 Triage ICH K223555Brainomix 360 e-CTP

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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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