OmniTrans 运输系统
K号: K240235 · 2024-08-19
广告
决定日期2024-08-19
产品代码JSM
咨询委员会抱歉，您提供的内容“MI”不足以进行翻译。请提供完整的医疗设备监管文本，以便我能够进行准确的翻译。
决定实质等同
器械摘要
OmniTrans Transport System is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Dakewe Bio-Engineering Co., Ltd.. It received FDA 510(k) clearance on 2024-08-19 under 510(k) number K240235. The device is classified under product code JSM. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the OmniTrans Transport System?
OmniTrans Transport System is a medical device that received FDA 510(k) clearance on 2024-08-19. The listed applicant is Shenzhen Dakewe Bio-Engineering Co., Ltd.. The 510(k) number is K240235.
When did OmniTrans Transport System receive FDA 510(k) clearance?
OmniTrans Transport System received FDA 510(k) clearance on 2024-08-19, under 510(k) number K240235.
Who is the listed applicant for OmniTrans Transport System?
The FDA 510(k) record lists Shenzhen Dakewe Bio-Engineering Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for OmniTrans Transport System?
The FDA product code for OmniTrans Transport System is JSM.
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Shenzhen Dakewe Bio-Engineering 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：JSM）
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。
K242976医疗电线粪便转拭液Cary Blair培养基收集和运输装置Medical Wire & Equipment Company (Bath), Ltd.K250205Babio® 病毒运输试剂盒（非灭活型）Jinan Babio Biotechnology Co., Ltd.K242576AllTest 病毒运输培养基Hangzhou AllTest Biotech Co., Ltd.K232565UriSponge™Copan Italia SpaK220908Ensol EnTM 样本收集和运输系统Ensol Biosciences, Inc.K233534病毒运输培养基Hardy Diagnostics
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