OEC One
K号: K182626 · 2018-11-16
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器械摘要
OEC One is the device name listed in this FDA 510(k) record. The listed applicant is Ge Hualun Medical Systems Co. , Ltd.. It received FDA 510(k) clearance on 2018-11-16 under 510(k) number K182626. The device is classified under product code OXO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the OEC One?
OEC One is a medical device that received FDA 510(k) clearance on 2018-11-16. The listed applicant is Ge Hualun Medical Systems Co. , Ltd.. The 510(k) number is K182626.
When did OEC One receive FDA 510(k) clearance?
OEC One received FDA 510(k) clearance on 2018-11-16, under 510(k) number K182626.
Who is the listed applicant for OEC One?
The FDA 510(k) record lists Ge Hualun Medical Systems Co. , Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for OEC One?
The FDA product code for OEC One is OXO.
列明Ge Hualun Medical Systems Co. , Ltd.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：OXO）
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。
K2532963D数字C-ARMAllengers Medical Systems LimitedK252579Orthoscan TAU MVP Mini C-Arm SystemZiehm-Orthoscan, Inc.K253269OEC One CFDGe Hualun Medical Systems Co. , Ltd.K251004双模式移动C-臂（Geelin500A，Geelin500M）Hefei Chimed Intelligent Machine Co., Ltd.K250587Orthoscan TAU Mini C-ArmZiehm-Orthoscan, Inc.K243452Orthoscan VERSA Mini C-ArmZiehm-Orthoscan, Inc.
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。
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