FDA 510(k)

CAIs Sensor (CAIs-001)

Номер K: K241160 · 2024-12-13

Дата решения2024-12-13

Код продуктаGXY

Консультативный комитетNE

РешениеSubstantially Equivalent

Описание устройства

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.

Часто задаваемые вопросы

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.

Связанные клинические исследования

Связанные записи сопоставляются автоматически на основании названий, кодов продукции или иных метаданных. Сопоставление не подтверждает клиническую, научную, корпоративную или регуляторную связь; ознакомьтесь с официальными источниками по ссылкам.

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Связанные устройства (Код: GXY)

K262654Dexus Prosthetic System (MSL2, MSR2)Zhejiang Qiangnao Technology Co.,Ltd K260578Ambu® NeurolineTM Cup MRI/CT (Модели 72704/21US, 72704/23US, 72704/25US, 72704/27US) Ambu® NeurolineTM Cup MRI/CT-set (Модели 72704/21-1010US, 72704/21-1010US, 72704/23-1010US, 72704/25-1010US, 72704/27-1010US) Ambu® NeurolineTM Cup MRI/CT-mini set (Модели 72704/21-0301US, 72704/23-0301US, 72704/25-0301US, 72704/27-0301US)Ambu A/S K261442Charlotte ACC25 Surface Electrode Array; Charlotte ACC25 Reusable Surface Electrode ArrayCadwell Industries, Inc.K261522BioWave BioWrapsBiowave Corporation K253237Elde Medical Electrodes (T5/ 5 cm x 5cm electrode T10/ 5 cm x 10cm electrode)Elde Medikal Sanayi ve Ticaret Anonim Sirketi K254183MR Conditional Cup ElectrodesTechnomed Europe

Официальный источник

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