Rio 瓶到袋药物复配装置
K号: K192154 · 2020-04-20
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申请人Icu Medical
决定日期2020-04-20
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 Vial-to-Bag Drug Reconstitution Device is the device name listed in this FDA 510(k) record. The listed applicant is Icu Medical. It received FDA 510(k) clearance on 2020-04-20 under 510(k) number K192154. 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 Vial-to-Bag Drug Reconstitution Device?
Rio Vial-to-Bag Drug Reconstitution Device is a medical device that received FDA 510(k) clearance on 2020-04-20. The listed applicant is Icu Medical. The 510(k) number is K192154.
When did Rio Vial-to-Bag Drug Reconstitution Device receive FDA 510(k) clearance?
Rio Vial-to-Bag Drug Reconstitution Device received FDA 510(k) clearance on 2020-04-20, under 510(k) number K192154.
Who is the listed applicant for Rio Vial-to-Bag Drug Reconstitution Device?
The FDA 510(k) record lists Icu Medical as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Rio Vial-to-Bag Drug Reconstitution Device?
The FDA product code for Rio Vial-to-Bag Drug Reconstitution 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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