BioZorb SP Marker
K号: K192371 · 2019-09-26
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决定日期2019-09-26
产品代码NEU
咨询委员会SU
请注意，您提供的文本“SU”不足以进行翻译。请提供完整的描述性文本以便进行翻译。
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器械摘要
BioZorb SP Marker is the device name listed in this FDA 510(k) record. The listed applicant is Focal Therapeutics. It received FDA 510(k) clearance on 2019-09-26 under 510(k) number K192371. The device is classified under product code NEU. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the BioZorb SP Marker?
BioZorb SP Marker is a medical device that received FDA 510(k) clearance on 2019-09-26. The listed applicant is Focal Therapeutics. The 510(k) number is K192371.
When did BioZorb SP Marker receive FDA 510(k) clearance?
BioZorb SP Marker received FDA 510(k) clearance on 2019-09-26, under 510(k) number K192371.
Who is the listed applicant for BioZorb SP Marker?
The FDA 510(k) record lists Focal Therapeutics as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for BioZorb SP Marker?
The FDA product code for BioZorb SP Marker is NEU.
相关临床试验
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列明Focal Therapeutics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：NEU）
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
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