Enivo™
K号: K223373 · 2023-04-07
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决定日期2023-04-07
产品代码BTA
咨询委员会SU
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决定实质等同
器械摘要
Enivo™ is the device name listed in this FDA 510(k) record. The listed applicant is Aroa Biosurgery , Ltd.. It received FDA 510(k) clearance on 2023-04-07 under 510(k) number K223373. The device is classified under product code BTA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Enivo™?
Enivo™ is a medical device that received FDA 510(k) clearance on 2023-04-07. The listed applicant is Aroa Biosurgery , Ltd.. The 510(k) number is K223373.
When did Enivo™ receive FDA 510(k) clearance?
Enivo™ received FDA 510(k) clearance on 2023-04-07, under 510(k) number K223373.
Who is the listed applicant for Enivo™?
The FDA 510(k) record lists Aroa Biosurgery , Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Enivo™?
The FDA product code for Enivo™ is BTA.
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Aroa Biosurgery , Ltd.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：BTA）
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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