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FDA 510(k)

CAIs Sensor (CAIs-001)

K-Number: K241160 · 2024-12-13

ApplicantBrainu Co., Ltd.
Decision Date2024-12-13
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

CAIs Sensor (CAIs-001) is the device name listed in this FDA 510(k) record. The listed applicant is Brainu Co., Ltd.. It received FDA 510(k) clearance on 2024-12-13 under 510(k) 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. The listed applicant is Brainu Co., Ltd.. The 510(k) number is K241160.

When did CAIs Sensor (CAIs-001) receive FDA 510(k) clearance?

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

Who is the listed applicant for CAIs Sensor (CAIs-001)?

The FDA 510(k) record lists Brainu Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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

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

Related Devices (Code: GXY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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.

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