FDA 510(k)

真智慧 CORI (CORI)

K 號：K212537 · 2021-11-03

決定日期2021-11-03

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 (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 2021-11-03 under 510(k) number K212537. 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 (CORI)?

REAL INTELLIGENCE CORI (CORI) is a medical device that received FDA 510(k) clearance on 2021-11-03. The listed applicant is Blue Belt Technologies, Inc.. The 510(k) number is K212537.

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

REAL INTELLIGENCE CORI (CORI) received FDA 510(k) clearance on 2021-11-03, under 510(k) number K212537.

Who is the listed applicant for REAL INTELLIGENCE CORI (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 (CORI)?

The FDA product code for REAL INTELLIGENCE CORI (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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