StarX-1，StarX-2，StarX PRO-1 和 StarX PRO-2
K号: K212103 · 2021-08-30
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申请人Fona S.R.L
决定日期2021-08-30
产品代码MUH
咨询委员会DE
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决定实质等同
器械摘要
StarX-1, StarX-2, StarX PRO-1 and StarX PRO-2 is the device name listed in this FDA 510(k) record. The listed applicant is Fona S.R.L. It received FDA 510(k) clearance on 2021-08-30 under 510(k) number K212103. 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 StarX-1, StarX-2, StarX PRO-1 and StarX PRO-2?
StarX-1, StarX-2, StarX PRO-1 and StarX PRO-2 is a medical device that received FDA 510(k) clearance on 2021-08-30. The listed applicant is Fona S.R.L. The 510(k) number is K212103.
When did StarX-1, StarX-2, StarX PRO-1 and StarX PRO-2 receive FDA 510(k) clearance?
StarX-1, StarX-2, StarX PRO-1 and StarX PRO-2 received FDA 510(k) clearance on 2021-08-30, under 510(k) number K212103.
Who is the listed applicant for StarX-1, StarX-2, StarX PRO-1 and StarX PRO-2?
The FDA 510(k) record lists Fona S.R.L as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for StarX-1, StarX-2, StarX PRO-1 and StarX PRO-2?
The FDA product code for StarX-1, StarX-2, StarX PRO-1 and StarX PRO-2 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Fona 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。
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