FibroScan 530 Compact
K号: K160524 · 2016-03-18
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器械摘要
FibroScan 530 Compact is the device name listed in this FDA 510(k) record. The listed applicant is Echosens. It received FDA 510(k) clearance on 2016-03-18 under 510(k) number K160524. 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 530 Compact?
FibroScan 530 Compact is a medical device that received FDA 510(k) clearance on 2016-03-18. The listed applicant is Echosens. The 510(k) number is K160524.
When did FibroScan 530 Compact receive FDA 510(k) clearance?
FibroScan 530 Compact received FDA 510(k) clearance on 2016-03-18, under 510(k) number K160524.
Who is the listed applicant for FibroScan 530 Compact?
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 530 Compact?
The FDA product code for FibroScan 530 Compact 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。
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 230K203273FibroScan® Family of Products (型号：502 Touch, 530 Compact, 430 Mini+ 和 630)K200655FibroScan® 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+)
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。
官方来源
在 FDA 数据库中查看 →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。
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