FDA 510(k)

REAL INTELLIGENCE™ CORI™

K号: K231963 · 2023-08-01

决定日期2023-08-01

产品代码OLO

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决定实质等同

器械摘要

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 2023-08-01 under 510(k) number K231963. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the REAL INTELLIGENCE™ CORI™?

REAL INTELLIGENCE™ CORI™ is a medical device that received FDA 510(k) clearance on 2023-08-01. The listed applicant is Blue Belt Technologies, Inc.. The 510(k) number is K231963.

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

REAL INTELLIGENCE™ CORI™ received FDA 510(k) clearance on 2023-08-01, under 510(k) number K231963.

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.

列明Blue Belt Technologies, Inc.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K260601REAL INTELLIGENCE™ CORI™K252841REAL INTELLIGENCE™ CORI™ XT (CORI XT)K250921CORIOGRAPH 术前规划和建模服务 K242272CORIOGRAPH 术前规划和建模服务 K240139Real Intelligence™ CORI™K221224REAL INTELLIGENCE CORI

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官方来源

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