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FDA 510(k)

Storz Medical Duolith SD1 T-Top & Tower System with C-Actor Sepia Handpiece

K号: K202112 · 2021-02-21

决定日期2021-02-21
产品代码PZL
咨询委员会SU 请注意,您提供的文本“SU”不足以进行翻译。请提供完整的描述性文本以便进行翻译。
决定实质等同

器械摘要

Storz Medical Duolith SD1 T-Top & Tower System with C-Actor Sepia Handpiece is the device name listed in this FDA 510(k) record. The listed applicant is Storz Medical AG. It received FDA 510(k) clearance on 2021-02-21 under 510(k) number K202112. The device is classified under product code PZL. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Storz Medical Duolith SD1 T-Top & Tower System with C-Actor Sepia Handpiece?

Storz Medical Duolith SD1 T-Top & Tower System with C-Actor Sepia Handpiece is a medical device that received FDA 510(k) clearance on 2021-02-21. The listed applicant is Storz Medical AG. The 510(k) number is K202112.

When did Storz Medical Duolith SD1 T-Top & Tower System with C-Actor Sepia Handpiece receive FDA 510(k) clearance?

Storz Medical Duolith SD1 T-Top & Tower System with C-Actor Sepia Handpiece received FDA 510(k) clearance on 2021-02-21, under 510(k) number K202112.

Who is the listed applicant for Storz Medical Duolith SD1 T-Top & Tower System with C-Actor Sepia Handpiece?

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

What is the FDA product code for Storz Medical Duolith SD1 T-Top & Tower System with C-Actor Sepia Handpiece?

The FDA product code for Storz Medical Duolith SD1 T-Top & Tower System with C-Actor Sepia Handpiece is PZL.

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Storz Medical AG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。

相关器械(代码:PZL)

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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