BioVision Plus
K号: K153583 · 2016-04-01
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器械摘要
BioVision Plus is the device name listed in this FDA 510(k) record. The listed applicant is Faxitron Bioptics, LLC. It received FDA 510(k) clearance on 2016-04-01 under 510(k) number K153583. The device is classified under product code MWP. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the BioVision Plus?
BioVision Plus is a medical device that received FDA 510(k) clearance on 2016-04-01. The listed applicant is Faxitron Bioptics, LLC. The 510(k) number is K153583.
When did BioVision Plus receive FDA 510(k) clearance?
BioVision Plus received FDA 510(k) clearance on 2016-04-01, under 510(k) number K153583.
Who is the listed applicant for BioVision Plus?
The FDA 510(k) record lists Faxitron Bioptics, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for BioVision Plus?
The FDA product code for BioVision Plus is MWP.
相关临床试验
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列明Faxitron Bioptics, LLC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：MWP）
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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