ResolutionMD
K号: K161130 · 2016-08-24
广告
器械摘要
ResolutionMD is the device name listed in this FDA 510(k) record. The listed applicant is Calgary Scientific, Inc.. It received FDA 510(k) clearance on 2016-08-24 under 510(k) number K161130. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
什么是ResolutionMD？
ResolutionMD is a medical device that received FDA 510(k) clearance on 2016-08-24. The listed applicant is Calgary Scientific, Inc.. The 510(k) number is K161130.
ResolutionMD何时获得FDA 510(k)批准？
ResolutionMD received FDA 510(k) clearance on 2016-08-24, under 510(k) number K161130.
ResolutionMD的列名申请人是谁？
The FDA 510(k) record lists Calgary Scientific, Inc. as the applicant. This does not by itself establish the device manufacturer.
什么是ResolutionMD的FDA产品代码？
FDA产品代码为ResolutionMD的是LLZ。
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。
相关器械（代码：LLZ）
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。
K261874Syneris PACS v.1.0.1.0SynerisK262442HipStudio分析Replasia BVK261855Elucid PlaqueIQElucid Bioimaging, Inc.K254214OOOPDS
请注意，由于您没有提供具体的医疗设备监管文本，我无法提供准确的翻译。如果您能提供具体的文本内容，我将能够为您提供准确的翻译。Taiwan Main Orthopaedic Biotechnology Co., Ltd.K261861SPINEsim v1.0Mdsim S.A.K2620603D-RD-SRadiopharmaceutical Imaging & Dosimetry, LLC
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