Tumark for Eviva，Tumark for Brevera
K号: K182082 · 2018-10-31
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决定日期2018-10-31
产品代码NEU
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
Tumark for Eviva, Tumark for Brevera is the device name listed in this FDA 510(k) record. The listed applicant is Somatex Medical Technologies GmbH. It received FDA 510(k) clearance on 2018-10-31 under 510(k) number K182082. The device is classified under product code NEU. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Tumark for Eviva, Tumark for Brevera?
Tumark for Eviva, Tumark for Brevera is a medical device that received FDA 510(k) clearance on 2018-10-31. The listed applicant is Somatex Medical Technologies GmbH. The 510(k) number is K182082.
When did Tumark for Eviva, Tumark for Brevera receive FDA 510(k) clearance?
Tumark for Eviva, Tumark for Brevera received FDA 510(k) clearance on 2018-10-31, under 510(k) number K182082.
Who is the listed applicant for Tumark for Eviva, Tumark for Brevera?
The FDA 510(k) record lists Somatex Medical Technologies GmbH as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Tumark for Eviva, Tumark for Brevera?
The FDA product code for Tumark for Eviva, Tumark for Brevera is NEU.
相关临床试验
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列明Somatex Medical Technologies GmbH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：NEU）
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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