体外冲击波碎石机（U200）
K号: K242922 · 2025-06-18
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决定日期2025-06-18
产品代码LNS
咨询委员会GU
请注意，由于您只提供了“GU”这个词，我无法提供完整的翻译。如果您能提供完整的句子或段落，我将能够为您提供准确的翻译。
决定实质等同
器械摘要
Extracorporeal Shock Wave Lithotripter (U200) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Wikkon Precision Technologies Co., Ltd.. It received FDA 510(k) clearance on 2025-06-18 under 510(k) number K242922. The device is classified under product code LNS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Extracorporeal Shock Wave Lithotripter (U200)?
Extracorporeal Shock Wave Lithotripter (U200) is a medical device that received FDA 510(k) clearance on 2025-06-18. The listed applicant is Shenzhen Wikkon Precision Technologies Co., Ltd.. The 510(k) number is K242922.
When did Extracorporeal Shock Wave Lithotripter (U200) receive FDA 510(k) clearance?
Extracorporeal Shock Wave Lithotripter (U200) received FDA 510(k) clearance on 2025-06-18, under 510(k) number K242922.
Who is the listed applicant for Extracorporeal Shock Wave Lithotripter (U200)?
The FDA 510(k) record lists Shenzhen Wikkon Precision Technologies Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Extracorporeal Shock Wave Lithotripter (U200)?
The FDA product code for Extracorporeal Shock Wave Lithotripter (U200) is LNS.
相关临床试验
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相关器械（代码：LNS）
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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