PreXion3D Excelsior
K号: K173878 · 2018-01-19
广告
器械摘要
PreXion3D Excelsior is the device name listed in this FDA 510(k) record. The listed applicant is Prexion Corporation. It received FDA 510(k) clearance on 2018-01-19 under 510(k) number K173878. The device is classified under product code OAS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the PreXion3D Excelsior?
PreXion3D Excelsior is a medical device that received FDA 510(k) clearance on 2018-01-19. The listed applicant is Prexion Corporation. The 510(k) number is K173878.
When did PreXion3D Excelsior receive FDA 510(k) clearance?
PreXion3D Excelsior received FDA 510(k) clearance on 2018-01-19, under 510(k) number K173878.
Who is the listed applicant for PreXion3D Excelsior?
The FDA 510(k) record lists Prexion Corporation as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for PreXion3D Excelsior?
The FDA product code for PreXion3D Excelsior is OAS.
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Prexion Corporation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：OAS）
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。
K261748牙科锥形束计算机断层扫描（mDX-15P系列）Hefei Meyer Optoelectronic Technology, Inc.K250839牙科 X-ray 系统Changzhou Boen Zhongding Medical Technology Co., Ltd.K260662牙科锥形束CT系统Yofo Medical Technology Co., Ltd.K253935medXion NEXUSmedXion Technologies, Inc.K260462RCT800Ray Co., Ltd.K260093Green X 12 VE (PHT-70CHS); Green X VE (PHT-70CHS)VATECH Co., Ltd.
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