哈利法克斯成像套件
K号: K182880 · 2018-10-31
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器械摘要
Halifax Imaging Kit is the device name listed in this FDA 510(k) record. The listed applicant is Halifax Biomedical, Inc.. It received FDA 510(k) clearance on 2018-10-31 under 510(k) number K182880. The device is classified under product code KPR. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Halifax Imaging Kit?
Halifax Imaging Kit is a medical device that received FDA 510(k) clearance on 2018-10-31. The listed applicant is Halifax Biomedical, Inc.. The 510(k) number is K182880.
When did Halifax Imaging Kit receive FDA 510(k) clearance?
Halifax Imaging Kit received FDA 510(k) clearance on 2018-10-31, under 510(k) number K182880.
Who is the listed applicant for Halifax Imaging Kit?
The FDA 510(k) record lists Halifax Biomedical, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Halifax Imaging Kit?
The FDA product code for Halifax Imaging Kit is KPR.
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：KPR）
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。
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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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