FDA 510(k)

CAIs Sensor (CAIs-001)

K-Number: K241160 · 2024-12-13

Decision Date2024-12-13

Product CodeGXY

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

CAIs Sensor (CAIs-001) is a medical device manufactured by Brainu Co., Ltd.. It received FDA 510(k) clearance on 2024-12-13 under approval number K241160. The device is classified under product code GXY. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CAIs Sensor (CAIs-001)?

CAIs Sensor (CAIs-001) is a medical device that received FDA 510(k) clearance on 2024-12-13. It is manufactured by Brainu Co., Ltd.. The 510(k) number is K241160.

When was CAIs Sensor (CAIs-001) approved by the FDA?

CAIs Sensor (CAIs-001) received FDA 510(k) clearance on 2024-12-13, under approval number K241160.

What company makes CAIs Sensor (CAIs-001)?

CAIs Sensor (CAIs-001) is manufactured by Brainu Co., Ltd..

What is the FDA product code for CAIs Sensor (CAIs-001)?

The FDA product code for CAIs Sensor (CAIs-001) is GXY.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.