E-Temp
K号: K211101 · 2021-06-14
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决定日期2021-06-14
产品代码EBG
咨询委员会DE
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决定实质等同
器械摘要
E-Temp is the device name listed in this FDA 510(k) record. The listed applicant is Envisiontec GmbH. It received FDA 510(k) clearance on 2021-06-14 under 510(k) number K211101. The device is classified under product code EBG. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the E-Temp?
E-Temp is a medical device that received FDA 510(k) clearance on 2021-06-14. The listed applicant is Envisiontec GmbH. The 510(k) number is K211101.
When did E-Temp receive FDA 510(k) clearance?
E-Temp received FDA 510(k) clearance on 2021-06-14, under 510(k) number K211101.
Who is the listed applicant for E-Temp?
The FDA 510(k) record lists Envisiontec GmbH as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for E-Temp?
The FDA product code for E-Temp is EBG.
列明Envisiontec 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：EBG）
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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