MEDRAD® 成像大批量包装转移套件
K号: K173913 · 2018-05-04
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决定日期2018-05-04
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
MEDRAD® Imaging Bulk Package Transfer Set is the device name listed in this FDA 510(k) record. The listed applicant is Bayer U.S., LLC. It received FDA 510(k) clearance on 2018-05-04 under 510(k) number K173913. 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 MEDRAD® Imaging Bulk Package Transfer Set?
MEDRAD® Imaging Bulk Package Transfer Set is a medical device that received FDA 510(k) clearance on 2018-05-04. The listed applicant is Bayer U.S., LLC. The 510(k) number is K173913.
When did MEDRAD® Imaging Bulk Package Transfer Set receive FDA 510(k) clearance?
MEDRAD® Imaging Bulk Package Transfer Set received FDA 510(k) clearance on 2018-05-04, under 510(k) number K173913.
Who is the listed applicant for MEDRAD® Imaging Bulk Package Transfer Set?
The FDA 510(k) record lists Bayer U.S., LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for MEDRAD® Imaging Bulk Package Transfer Set?
The FDA product code for MEDRAD® Imaging Bulk Package 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。
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。
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