DiaTemp
K号: K192158 · 2020-02-13
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决定日期2020-02-13
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
DiaTemp is the device name listed in this FDA 510(k) record. The listed applicant is DiaDent Group International. It received FDA 510(k) clearance on 2020-02-13 under 510(k) number K192158. 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 DiaTemp?
DiaTemp is a medical device that received FDA 510(k) clearance on 2020-02-13. The listed applicant is DiaDent Group International. The 510(k) number is K192158.
When did DiaTemp receive FDA 510(k) clearance?
DiaTemp received FDA 510(k) clearance on 2020-02-13, under 510(k) number K192158.
Who is the listed applicant for DiaTemp?
FDA 510(k)记录显示DiaDent Group International为申请人。这本身并不能确立该设备制造商的身份。
What is the FDA product code for DiaTemp?
The FDA product code for DiaTemp is EBG.
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。
列明DiaDent Group International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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