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FDA 510(k)

FibroScan® Family of Products (型号：502 Touch, 530 Compact, 430 Mini+ 和 630)

K号: K203273 · 2021-03-25

申请人Echosens
决定日期2021-03-25
产品代码IYO
咨询委员会RA
决定实质等同

器械摘要

FibroScan® Family of Products (Models: 502 Touch, 530 Compact, 430 Mini+, and 630) is the device name listed in this FDA 510(k) record. The listed applicant is Echosens. It received FDA 510(k) clearance on 2021-03-25 under 510(k) number K203273. 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® Family of Products (Models: 502 Touch, 530 Compact, 430 Mini+, and 630)?

FibroScan® Family of Products (Models: 502 Touch, 530 Compact, 430 Mini+, and 630) is a medical device that received FDA 510(k) clearance on 2021-03-25. The listed applicant is Echosens. The 510(k) number is K203273.

When did FibroScan® Family of Products (Models: 502 Touch, 530 Compact, 430 Mini+, and 630) receive FDA 510(k) clearance?

FibroScan® Family of Products (Models: 502 Touch, 530 Compact, 430 Mini+, and 630) received FDA 510(k) clearance on 2021-03-25, under 510(k) number K203273.

Who is the listed applicant for FibroScan® Family of Products (Models: 502 Touch, 530 Compact, 430 Mini+, and 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® Family of Products (Models: 502 Touch, 530 Compact, 430 Mini+, and 630)?

The FDA product code for FibroScan® Family of Products (Models: 502 Touch, 530 Compact, 430 Mini+, and 630) is IYO.

相关临床试验

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。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

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 230K200655FibroScan® 630K181547FibroScan® 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+

查看所有 8 个设备 →

相关器械（代码：IYO）

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。

K260313MD-6000S 膀胱扫描仪MEDA Co., Ltd.K253452Accuro 3SRivanna Medical, Inc.K260190ARTHURROPCA ApSK252237EdgeFlow UW20Edgecare, Inc.K254021Accuro XVRivanna Medical, Inc.K253898QT Scanner 2000 型号 AQT Imaging Holdings, Inc.

官方来源

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