FDA 510(k)

REAL INTELLIGENCE™ CORI™

K 號：K260601 · 2026-03-26

決定日期2026-03-26

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 2026-03-26 under 510(k) number K260601. 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 2026-03-26. The listed applicant is Blue Belt Technologies, Inc.. The 510(k) number is K260601.

When did REAL INTELLIGENCE™ CORI™ receive FDA 510(k) clearance?

REAL INTELLIGENCE™ CORI™ received FDA 510(k) clearance on 2026-03-26, under 510(k) number K260601.

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.

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）

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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