TheraBase, TheraBase Ca
K号: K192007 · 2020-03-17
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申请人Bisco, Inc.
决定日期2020-03-17
产品代码EMA
咨询委员会DE
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决定实质等同
器械摘要
TheraBase, TheraBase Ca is the device name listed in this FDA 510(k) record. The listed applicant is Bisco, Inc.. It received FDA 510(k) clearance on 2020-03-17 under 510(k) number K192007. The device is classified under product code EMA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the TheraBase, TheraBase Ca?
TheraBase, TheraBase Ca is a medical device that received FDA 510(k) clearance on 2020-03-17. The listed applicant is Bisco, Inc.. The 510(k) number is K192007.
When did TheraBase, TheraBase Ca receive FDA 510(k) clearance?
TheraBase, TheraBase Ca received FDA 510(k) clearance on 2020-03-17, under 510(k) number K192007.
Who is the listed applicant for TheraBase, TheraBase Ca?
The FDA 510(k) record lists Bisco, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for TheraBase, TheraBase Ca?
The FDA product code for TheraBase, TheraBase Ca is EMA.
相关临床试验
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列明Bisco, Inc.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：EMA）
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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