3D 自动LAA
K号: K201352 · 2020-08-17
广告
器械摘要
3D Auto LAA is the device name listed in this FDA 510(k) record. The listed applicant is Philips Health Care. It received FDA 510(k) clearance on 2020-08-17 under 510(k) number K201352. 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 3D Auto LAA?
3D Auto LAA is a medical device that received FDA 510(k) clearance on 2020-08-17. The listed applicant is Philips Health Care. The 510(k) number is K201352.
When did 3D Auto LAA receive FDA 510(k) clearance?
3D Auto LAA received FDA 510(k) clearance on 2020-08-17, under 510(k) number K201352.
Who is the listed applicant for 3D Auto LAA?
The FDA 510(k) record lists Philips Health Care as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for 3D Auto LAA?
The FDA product code for 3D Auto LAA is LLZ.
列明Philips Health Care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：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