Fusion Bx 2.0
K号: K181290 · 2018-06-15
广告
器械摘要
Fusion Bx 2.0 is the device name listed in this FDA 510(k) record. The listed applicant is Focal Healthcare, Inc.. It received FDA 510(k) clearance on 2018-06-15 under 510(k) number K181290. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Fusion Bx 2.0?
Fusion Bx 2.0 is a medical device that received FDA 510(k) clearance on 2018-06-15. The listed applicant is Focal Healthcare, Inc.. The 510(k) number is K181290.
When did Fusion Bx 2.0 receive FDA 510(k) clearance?
Fusion Bx 2.0 received FDA 510(k) clearance on 2018-06-15, under 510(k) number K181290.
Who is the listed applicant for Fusion Bx 2.0?
The FDA 510(k) record lists Focal Healthcare, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Fusion Bx 2.0?
The FDA product code for Fusion Bx 2.0 is 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