LaborView™ LV1000 无线电极系统
K号: K190798 · 2020-09-18
广告
决定日期2020-09-18
产品代码OSP
咨询委员会OB
请注意，由于您没有提供具体的医疗设备监管文本，我无法进行翻译。请提供具体的文本内容，以便我能够按照您的要求进行翻译。
决定实质等同
器械摘要
LaborView™ LV1000 Wireless Electrode System is the device name listed in this FDA 510(k) record. The listed applicant is Obmedical Company. It received FDA 510(k) clearance on 2020-09-18 under 510(k) number K190798. The device is classified under product code OSP. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the LaborView™ LV1000 Wireless Electrode System?
LaborView™ LV1000 Wireless Electrode System is a medical device that received FDA 510(k) clearance on 2020-09-18. The listed applicant is Obmedical Company. The 510(k) number is K190798.
When did LaborView™ LV1000 Wireless Electrode System receive FDA 510(k) clearance?
LaborView™ LV1000 Wireless Electrode System received FDA 510(k) clearance on 2020-09-18, under 510(k) number K190798.
Who is the listed applicant for LaborView™ LV1000 Wireless Electrode System?
The FDA 510(k) record lists Obmedical Company as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for LaborView™ LV1000 Wireless Electrode System?
The FDA product code for LaborView™ LV1000 Wireless Electrode System is OSP.
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：OSP）
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。
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