Ambu Duodeno 系统
K号: K201098 · 2020-07-17
广告
决定日期2020-07-17
产品代码FDT
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
Ambu Duodeno System is the device name listed in this FDA 510(k) record. The listed applicant is Ambu Innovation GmbH. It received FDA 510(k) clearance on 2020-07-17 under 510(k) number K201098. The device is classified under product code FDT. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Ambu Duodeno System?
Ambu Duodeno System is a medical device that received FDA 510(k) clearance on 2020-07-17. The listed applicant is Ambu Innovation GmbH. The 510(k) number is K201098.
When did Ambu Duodeno System receive FDA 510(k) clearance?
Ambu Duodeno System received FDA 510(k) clearance on 2020-07-17, under 510(k) number K201098.
Who is the listed applicant for Ambu Duodeno System?
The FDA 510(k) record lists Ambu Innovation GmbH as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Ambu Duodeno System?
The FDA product code for Ambu Duodeno System is FDT.
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：FDT）
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。
K251861富士胶片内窥镜型号ED-S100TP; 富士胶片内窥镜型号ED-S100XP; 富士胶片处理器型号VS-1000Fujifilm CorporationK253646一次性远端盖 MAJ-2315 (MAJ-2315)Olympus Medical Systems Corp.K251867EVIS EXERA III 十二指肠镜 OLYMPUS TJF-Q190V (TJF-Q190V)Olympus Medical Systems Corp.K250701Evis Exera III十二指肠内窥镜Olympus TJF-Q190V（TJF-Q190V）Olympus Medical Systems Corp.K233942PENTAX 医疗视频十二指肠镜 (ED34-i10T2s)；PENTAX 医疗视频处理器 (EPK-i8020c)；PENTAX 医疗一次性，无菌远端帽带提升器 (OE-A63)；气/水供应阀门 (OF-B194 )Pentax of America, Inc.K233886Ambu® aScope™ Duodeno 2, Ambu® aBox™ 2Ambu A/S
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。
广告