Clio Prime和Clio Pedo
K号: K202664 · 2020-11-06
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决定日期2020-11-06
产品代码MUH
咨询委员会DE
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器械摘要
Clio Prime and Clio Pedo is the device name listed in this FDA 510(k) record. The listed applicant is Sota Precision Optics, Inc. Dba Sota Imaging. It received FDA 510(k) clearance on 2020-11-06 under 510(k) number K202664. 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 Clio Prime and Clio Pedo?
Clio Prime and Clio Pedo is a medical device that received FDA 510(k) clearance on 2020-11-06. The listed applicant is Sota Precision Optics, Inc. Dba Sota Imaging. The 510(k) number is K202664.
When did Clio Prime and Clio Pedo receive FDA 510(k) clearance?
Clio Prime and Clio Pedo received FDA 510(k) clearance on 2020-11-06, under 510(k) number K202664.
Who is the listed applicant for Clio Prime and Clio Pedo?
The FDA 510(k) record lists Sota Precision Optics, Inc. Dba Sota Imaging as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Clio Prime and Clio Pedo?
The FDA product code for Clio Prime and Clio Pedo 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Sota Precision Optics, Inc. Dba Sota Imaging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。
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