SmartSurgN 视觉化系统
K号: K213943 · 2022-11-29
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决定日期2022-11-29
产品代码OWN
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
SmartSurgN Visualization System is the device name listed in this FDA 510(k) record. The listed applicant is Smartsurgn Incorporated. It received FDA 510(k) clearance on 2022-11-29 under 510(k) number K213943. The device is classified under product code OWN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the SmartSurgN Visualization System?
SmartSurgN Visualization System is a medical device that received FDA 510(k) clearance on 2022-11-29. The listed applicant is Smartsurgn Incorporated. The 510(k) number is K213943.
When did SmartSurgN Visualization System receive FDA 510(k) clearance?
SmartSurgN Visualization System received FDA 510(k) clearance on 2022-11-29, under 510(k) number K213943.
Who is the listed applicant for SmartSurgN Visualization System?
The FDA 510(k) record lists Smartsurgn Incorporated as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for SmartSurgN Visualization System?
The FDA product code for SmartSurgN Visualization System is OWN.
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。
相关器械（代码：OWN）
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。
K262547KARL STORZ TIPCAM1 RubinaKALR STORZ SE & Co. KGK254180PerfusiX-影像LIMIS Development B.V.K242163SmartSurgN 视觉化系统SmartsurgN, Inc.K254242KARL STORZ ICG成像系统带RUBINA®镜头Karl Storz SE & CO. KGK251852cCeLL - 在体内使用Drop-In Robo（CN100-2W2C488775，CN100-1W1C775，DR200）VPIX Medical, Inc.K253972IMAGE1 (TC400US)；X-to-4U 适配器 (TC040)Karl Storz SE & CO. KG
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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