科博斯脉搏血糖监测系统
K号: K220272 · 2024-04-26
广告
决定日期2024-04-26
产品代码PZI
咨询委员会CH
请注意，您提供的文本“CH”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
cobas pulse blood glucose monitoring system is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics. It received FDA 510(k) clearance on 2024-04-26 under 510(k) number K220272. The device is classified under product code PZI. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the cobas pulse blood glucose monitoring system?
cobas pulse blood glucose monitoring system is a medical device that received FDA 510(k) clearance on 2024-04-26. The listed applicant is Roche Diagnostics. The 510(k) number is K220272.
When did cobas pulse blood glucose monitoring system receive FDA 510(k) clearance?
cobas pulse blood glucose monitoring system received FDA 510(k) clearance on 2024-04-26, under 510(k) number K220272.
Who is the listed applicant for cobas pulse blood glucose monitoring system?
FDA 510(k)记录显示罗氏诊断公司为申请人。这本身并不能确立该设备的制造商。
What is the FDA product code for cobas pulse blood glucose monitoring system?
The FDA product code for cobas pulse blood glucose monitoring system is PZI.
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Roche Diagnostics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：PZI）
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。
K252323科博斯脉搏血糖监测系统Roche DiagnosticsK221349XPER技术 PREMIUM Pro 血糖监测系统Taidoc Technology CorporationK232075StatStrip葡萄糖医院计量系统Nova Biomedical CorporationK200788Assure钛血葡萄糖监测系统Arkray, Inc.K182552StatStrip Xpress葡萄糖医院计量系统Nova Biomedical CorporationK182549StatStrip Xpress 2葡萄糖医院计量系统Nova Biomedical Corporation
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