乌尔里希输血套装
K号: K161723 · 2016-12-21
广告
决定日期2016-12-21
产品代码PQH
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
ulrich Transfer Set is the device name listed in this FDA 510(k) record. The listed applicant is Ulrich GmbH & Co. KG. It received FDA 510(k) clearance on 2016-12-21 under 510(k) number K161723. The device is classified under product code PQH. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the ulrich Transfer Set?
ulrich Transfer Set is a medical device that received FDA 510(k) clearance on 2016-12-21. The listed applicant is Ulrich GmbH & Co. KG. The 510(k) number is K161723.
When did ulrich Transfer Set receive FDA 510(k) clearance?
ulrich Transfer Set received FDA 510(k) clearance on 2016-12-21, under 510(k) number K161723.
Who is the listed applicant for ulrich Transfer Set?
The FDA 510(k) record lists Ulrich GmbH & Co. KG as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for ulrich Transfer Set?
The FDA product code for ulrich Transfer Set is PQH.
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Ulrich GmbH & Co. KG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。
K252281ulricheasyINJECT Max 2M（XD 10140）；ulricheasyINJECT Max 3（XD 10150）；ulricheasyINJECT Max 3（XD 10180）K251295ulrich注射CT运动（XD 8000）K241850ulricheasyINJECT Max 2M（XD 10140）；ulricheasyINJECT Max 3（XD 10150）；ulricheasyINJECT Max 3（XD 10180）K233737ulricheasyINJECT Max 2M（XD 10140）；ulricheasyINJECT Max 3（XD 10150）；ulricheasyINJECT Max 3（XD 10180）K210541ulrich注射CT运动K202227Artus™颈椎板系统
相关器械（代码：PQH）
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。
广告