Titan安全套
K号: K210208 · 2022-02-17
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决定日期2022-02-17
产品代码HIS
咨询委员会OB
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决定实质等同
器械摘要
Titan Condoms is the device name listed in this FDA 510(k) record. The listed applicant is Titan Condoms, LLC. It received FDA 510(k) clearance on 2022-02-17 under 510(k) number K210208. The device is classified under product code HIS. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Titan Condoms?
Titan Condoms is a medical device that received FDA 510(k) clearance on 2022-02-17. The listed applicant is Titan Condoms, LLC. The 510(k) number is K210208.
When did Titan Condoms receive FDA 510(k) clearance?
Titan Condoms received FDA 510(k) clearance on 2022-02-17, under 510(k) number K210208.
Who is the listed applicant for Titan Condoms?
The FDA 510(k) record lists Titan Condoms, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Titan Condoms?
The FDA product code for Titan Condoms is HIS.
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。
相关器械（代码：HIS）
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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