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FDA 510(k)

Synq 软件版本 1.3

K号: K232981 · 2023-10-11

决定日期2023-10-11
产品代码LNH
咨询委员会RA
决定实质等同

器械摘要

Synq Software Version 1.3 is the device name listed in this FDA 510(k) record. The listed applicant is Synaptive Medical, Inc.. It received FDA 510(k) clearance on 2023-10-11 under 510(k) number K232981. 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 Synq Software Version 1.3?

Synq Software Version 1.3 is a medical device that received FDA 510(k) clearance on 2023-10-11. The listed applicant is Synaptive Medical, Inc.. The 510(k) number is K232981.

When did Synq Software Version 1.3 receive FDA 510(k) clearance?

Synq Software Version 1.3 received FDA 510(k) clearance on 2023-10-11, under 510(k) number K232981.

Who is the listed applicant for Synq Software Version 1.3?

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

What is the FDA product code for Synq Software Version 1.3?

The FDA product code for Synq Software Version 1.3 is LNH.

相关临床试验

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列明Synaptive Medical, Inc.为申报人的其他记录

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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

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