泰坦3W
K号: K160835 · 2017-02-02
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决定日期2017-02-02
产品代码INI
咨询委员会PM
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决定实质等同
器械摘要
Titan 3W is the device name listed in this FDA 510(k) record. The listed applicant is Tzora Active Systems , Ltd.. It received FDA 510(k) clearance on 2017-02-02 under 510(k) number K160835. The device is classified under product code INI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Titan 3W?
Titan 3W is a medical device that received FDA 510(k) clearance on 2017-02-02. The listed applicant is Tzora Active Systems , Ltd.. The 510(k) number is K160835.
When did Titan 3W receive FDA 510(k) clearance?
Titan 3W received FDA 510(k) clearance on 2017-02-02, under 510(k) number K160835.
Who is the listed applicant for Titan 3W?
The FDA 510(k) record lists Tzora Active Systems , Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Titan 3W?
The FDA product code for Titan 3W is INI.
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Tzora Active Systems , 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：INI）
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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