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FDA 510(k)

S-scan Open (100001800)

K号: K260746 · 2026-03-27

决定日期2026-03-27
产品代码LNH
咨询委员会RA
决定实质等同

器械摘要

S-scan Open (100001800) is the device name listed in this FDA 510(k) record. The listed applicant is Esaote, S.p.A.. It received FDA 510(k) clearance on 2026-03-27 under 510(k) number K260746. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the S-scan Open (100001800)?

S-scan Open (100001800) is a medical device that received FDA 510(k) clearance on 2026-03-27. The listed applicant is Esaote, S.p.A.. The 510(k) number is K260746.

When did S-scan Open (100001800) receive FDA 510(k) clearance?

S-scan Open (100001800) received FDA 510(k) clearance on 2026-03-27, under 510(k) number K260746.

Who is the listed applicant for S-scan Open (100001800)?

FDA 510(k)记录中列出Esaote, S.p.A.为申请人。这本身并不能确立该设备的制造商。

What is the FDA product code for S-scan Open (100001800)?

The FDA product code for S-scan Open (100001800) is LNH.

列明Esaote, S.p.A.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。

查看所有 25 个设备 →

相关器械(代码:LNH)

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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