Rio® 药物复配转移装置
K号: K243985 · 2025-01-22
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决定日期2025-01-22
产品代码LHI
咨询委员会医疗设备监管文本翻译如下：
HO
请注意，由于您没有提供具体的医疗设备监管文本内容，以上仅为示例。请提供具体的文本内容以便进行准确的翻译。
决定实质等同
器械摘要
Rio™ Drug Reconstitution Transfer Device is the device name listed in this FDA 510(k) record. The listed applicant is Icu Medical, Inc.. It received FDA 510(k) clearance on 2025-01-22 under 510(k) number K243985. The device is classified under product code LHI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Rio™ Drug Reconstitution Transfer Device?
Rio™ Drug Reconstitution Transfer Device is a medical device that received FDA 510(k) clearance on 2025-01-22. The listed applicant is Icu Medical, Inc.. The 510(k) number is K243985.
When did Rio™ Drug Reconstitution Transfer Device receive FDA 510(k) clearance?
Rio™ Drug Reconstitution Transfer Device received FDA 510(k) clearance on 2025-01-22, under 510(k) number K243985.
Who is the listed applicant for Rio™ Drug Reconstitution Transfer Device?
The FDA 510(k) record lists Icu Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Rio™ Drug Reconstitution Transfer Device?
The FDA product code for Rio™ Drug Reconstitution Transfer Device is LHI.
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Icu Medical, Inc.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：LHI）
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。
K252987ADRx® 混合设备Epic Medical Pte. , Ltd.K260301药瓶适配器Hangzhou Qiantang Longyue Biotechnology Co., Ltd.K250345Medline 袋式过滤器Medline Industries, LPK251715FlowArt® 安瓿瓶接入通风装置Asset MedikalK251676Medline Microtek C-Flo 瓶式过滤器，无菌（2000S）；Medline Microtek 瓶式过滤器 II，无菌（2002S）；Medline Microtek 瓶式过滤器，无菌（2006S）；Medline Microtek 转移装置，无菌（2008S）Microtek Medical, LLCK243404HyHub™ 和 HyHub™ Duo 瓶盖访问设备Takeda Pharmaceuticals
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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