Encevis
K号: K211452 · 2021-12-02
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决定日期2021-12-02
产品代码OMB
咨询委员会NE
请注意，您提供的文本“NE”不足以进行翻译，因为它不是一个完整的句子或描述。请提供完整的医疗设备监管文本，以便我能够进行准确的翻译。
决定实质等同
器械摘要
Encevis is the device name listed in this FDA 510(k) record. The listed applicant is Austrian Institute of Technology GmbH. It received FDA 510(k) clearance on 2021-12-02 under 510(k) number K211452. The device is classified under product code OMB. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Encevis?
Encevis is a medical device that received FDA 510(k) clearance on 2021-12-02. The listed applicant is Austrian Institute of Technology GmbH. The 510(k) number is K211452.
When did Encevis receive FDA 510(k) clearance?
Encevis received FDA 510(k) clearance on 2021-12-02, under 510(k) number K211452.
Who is the listed applicant for Encevis?
The FDA 510(k) record lists Austrian Institute of Technology GmbH as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Encevis?
The FDA product code for Encevis is OMB.
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相关器械（代码：OMB）
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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