ExamVue Duo
K号: K213057 · 2022-02-18
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器械摘要
ExamVue Duo is the device name listed in this FDA 510(k) record. The listed applicant is Jpi Healthcare Co, Ltd.. It received FDA 510(k) clearance on 2022-02-18 under 510(k) number K213057. The device is classified under product code KPR. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the ExamVue Duo?
ExamVue Duo is a medical device that received FDA 510(k) clearance on 2022-02-18. The listed applicant is Jpi Healthcare Co, Ltd.. The 510(k) number is K213057.
When did ExamVue Duo receive FDA 510(k) clearance?
ExamVue Duo received FDA 510(k) clearance on 2022-02-18, under 510(k) number K213057.
Who is the listed applicant for ExamVue Duo?
The FDA 510(k) record lists Jpi Healthcare Co, Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for ExamVue Duo?
The FDA product code for ExamVue Duo is KPR.
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Jpi Healthcare Co, Ltd.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：KPR）
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。
K260227EXSYS DEXi（EXSYS DEXi-S40S）；EXSYS DEXi（EXSYS DEXi-S40P）；EXSYS DEXi（EXSYS DEXi-S40T）；EXSYS DEXi（EXSYS DEXi-S50H）DRTECH CorporationK260488MULTIX Impact；MULTIX Impact CSiemens Medical Solutions USA, Inc.K260481GC85ASamsung Electronics Co., Ltd.K260482DRE DuoJpi Healthcare Co, Ltd.K253446AeroDR TX c02Dk Medical Systems Co., Ltd.K250954DRX-Evolution Plus X射线系统，DRX-Compass 移动X射线系统，Lux HD 35探测器，Lux HD 43探测器Carestream Health
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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