X-MIND 三冠
K号: K191719 · 2020-02-20
广告
决定日期2020-02-20
产品代码MUH
咨询委员会DE
请注意，您没有提供具体的医疗设备监管文本内容，因此我无法进行翻译。请提供需要翻译的具体文本，我将根据您的要求进行翻译。
决定实质等同
器械摘要
X-MIND Trium is the device name listed in this FDA 510(k) record. The listed applicant is De Gotzen S.R.L.. It received FDA 510(k) clearance on 2020-02-20 under 510(k) number K191719. The device is classified under product code MUH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the X-MIND Trium?
X-MIND Trium is a medical device that received FDA 510(k) clearance on 2020-02-20. The listed applicant is De Gotzen S.R.L.. The 510(k) number is K191719.
When did X-MIND Trium receive FDA 510(k) clearance?
X-MIND Trium received FDA 510(k) clearance on 2020-02-20, under 510(k) number K191719.
Who is the listed applicant for X-MIND Trium?
The FDA 510(k) record lists De Gotzen S.R.L. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for X-MIND Trium?
The FDA product code for X-MIND Trium is MUH.
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De Gotzen S.R.L.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：MUH）
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。
K251793SOTA Cloud Smart Sensor (1.5)Sota Cloud Corp.K252570EzSensor HD, EzSensor UHDQpix Solutions, Inc.K250687茧状单机（DX-7020s）Dexcowin Global, Inc.K251206Digital X-Ray DentiMax Pro Imaging SystemDentimax, Inc.K240040VistaPano S Ceph 2.0（VistaPano S Ceph）；VistaPano S 2.0（VistaPano S）；ProVecta S-Pan Ceph 2.0（ProVecta S-Pan Ceph）；ProVecta S-Pan 2.0（ProVecta S-Pan）VATECH Co., Ltd.K242778X传感器（型号：IOS-A15IF，HDI-15DGF）Qpix Solutions, Inc.
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。
广告