Deka Tiac II
K号: K211091 · 2021-10-15
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决定日期2021-10-15
产品代码PBX
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。
决定实质等同
器械摘要
Deka Tiac II is the device name listed in this FDA 510(k) record. The listed applicant is El.En Electronic Engineering Spa. It received FDA 510(k) clearance on 2021-10-15 under 510(k) number K211091. The device is classified under product code PBX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Deka Tiac II?
Deka Tiac II is a medical device that received FDA 510(k) clearance on 2021-10-15. The listed applicant is El.En Electronic Engineering Spa. The 510(k) number is K211091.
When did Deka Tiac II receive FDA 510(k) clearance?
Deka Tiac II received FDA 510(k) clearance on 2021-10-15, under 510(k) number K211091.
Who is the listed applicant for Deka Tiac II?
The FDA 510(k) record lists El.En Electronic Engineering Spa as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Deka Tiac II?
The FDA product code for Deka Tiac II is PBX.
列明El.En Electronic Engineering Spa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：PBX）
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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