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FDA 510(k)

真智慧™ CORI™

K 號:K240139 · 2024-03-18

決定日期2024-03-18
產品代碼OLO
諮詢委員會NE (請提供完整的英文描述,以便進行翻譯。)
決定相當於

器材摘要

Real Intelligence™ CORI™ is the device name listed in this FDA 510(k) record. The listed applicant is Blue Belt Technologies, Inc.. It received FDA 510(k) clearance on 2024-03-18 under 510(k) number K240139. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Real Intelligence™ CORI™?

Real Intelligence™ CORI™ is a medical device that received FDA 510(k) clearance on 2024-03-18. The listed applicant is Blue Belt Technologies, Inc.. The 510(k) number is K240139.

When did Real Intelligence™ CORI™ receive FDA 510(k) clearance?

Real Intelligence™ CORI™ received FDA 510(k) clearance on 2024-03-18, under 510(k) number K240139.

Who is the listed applicant for Real Intelligence™ CORI™?

The FDA 510(k) record lists Blue Belt Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Real Intelligence™ CORI™?

The FDA product code for Real Intelligence™ CORI™ is OLO.

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其他以 Blue Belt Technologies, Inc. 為申請人之記錄

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相關器械(代碼:OLO)

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官方來源

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