Pre-Sure
K号: K230044 · 2023-05-26
广告
器械摘要
Pre-Sure is the device name listed in this FDA 510(k) record. The listed applicant is Lazarus 3D. It received FDA 510(k) clearance on 2023-05-26 under 510(k) number K230044. 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 Pre-Sure?
Pre-Sure is a medical device that received FDA 510(k) clearance on 2023-05-26. The listed applicant is Lazarus 3D. The 510(k) number is K230044.
When did Pre-Sure receive FDA 510(k) clearance?
Pre-Sure received FDA 510(k) clearance on 2023-05-26, under 510(k) number K230044.
Who is the listed applicant for Pre-Sure?
The FDA 510(k) record lists Lazarus 3D as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Pre-Sure?
The FDA product code for Pre-Sure is LLZ.
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