FDA 510(k)

NAVIO

K号: K191223 · 2019-06-28

决定日期2019-06-28

产品代码OLO

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决定实质等同

器械摘要

NAVIO 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 2019-06-28 under 510(k) number K191223. 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 NAVIO?

NAVIO is a medical device that received FDA 510(k) clearance on 2019-06-28. The listed applicant is Blue Belt Technologies, Inc.. The 510(k) number is K191223.

When did NAVIO receive FDA 510(k) clearance?

NAVIO received FDA 510(k) clearance on 2019-06-28, under 510(k) number K191223.

Who is the listed applicant for NAVIO?

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 NAVIO?

The FDA product code for NAVIO 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™K231963REAL INTELLIGENCE™ CORI™

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