CAIs感測器（CAIs-001）
K 號：K241160 · 2024-12-13
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器材摘要
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.
常見問題
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.
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相關器械（代碼：GXY）
相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。
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官方來源
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