FDA 510(k)

FibroScan® 630

K号: K200655 · 2020-07-16

决定日期2020-07-16

产品代码IYO

咨询委员会RA

决定实质等同

器械摘要

FibroScan® 630 is the device name listed in this FDA 510(k) record. The listed applicant is Echosens. It received FDA 510(k) clearance on 2020-07-16 under 510(k) number K200655. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the FibroScan® 630?

FibroScan® 630 is a medical device that received FDA 510(k) clearance on 2020-07-16. The listed applicant is Echosens. The 510(k) number is K200655.

When did FibroScan® 630 receive FDA 510(k) clearance?

FibroScan® 630 received FDA 510(k) clearance on 2020-07-16, under 510(k) number K200655.

Who is the listed applicant for FibroScan® 630?

The FDA 510(k) record lists Echosens as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FibroScan® 630?

The FDA product code for FibroScan® 630 is IYO.

列明Echosens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。

K223902FibroScan® device (型号：502 Touch, 530 Compact, 430 Mini+, 230 和 630)K212035FibroScan 230 K203273FibroScan® Family of Products (型号：502 Touch, 530 Compact, 430 Mini+ 和 630)K181547FibroScan® Family of Products (型号：502 Touch, 530 Compact 和 430 Mini+)K173034FibroScan® Family of Products (型号：502 Touch, 530 Compact 和 430 Mini+)K172142FibroScan 430 Mini+

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官方来源

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数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。