Ambu VivaSight 2 DLT，Ambu VivaSight 2 适配器电缆
K号: K203749 · 2021-05-03
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申请人Ambu A/S
决定日期2021-05-03
产品代码CBI
咨询委员会AN
请注意，由于您没有提供完整的医疗设备监管文本，我无法提供完整的翻译。如果您能提供完整的文本，我将很乐意为您翻译。
决定实质等同
器械摘要
Ambu VivaSight 2 DLT, Ambu VivaSight 2 Adapter Cable is the device name listed in this FDA 510(k) record. The listed applicant is Ambu A/S. It received FDA 510(k) clearance on 2021-05-03 under 510(k) number K203749. The device is classified under product code CBI. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Ambu VivaSight 2 DLT, Ambu VivaSight 2 Adapter Cable?
Ambu VivaSight 2 DLT, Ambu VivaSight 2 Adapter Cable is a medical device that received FDA 510(k) clearance on 2021-05-03. The listed applicant is Ambu A/S. The 510(k) number is K203749.
When did Ambu VivaSight 2 DLT, Ambu VivaSight 2 Adapter Cable receive FDA 510(k) clearance?
Ambu VivaSight 2 DLT, Ambu VivaSight 2 Adapter Cable received FDA 510(k) clearance on 2021-05-03, under 510(k) number K203749.
Who is the listed applicant for Ambu VivaSight 2 DLT, Ambu VivaSight 2 Adapter Cable?
FDA 510(k)记录显示Ambu A/S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 Ambu VivaSight 2 DLT, Ambu VivaSight 2 Adapter Cable?
The FDA product code for Ambu VivaSight 2 DLT, Ambu VivaSight 2 Adapter Cable is CBI.
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Ambu A/S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。
K260309Ambu® aScope™ 5 Broncho 2.7/1.2；Ambu® aScope™ 5 Broncho 4.2/2.2；Ambu® aScope™ 5 Broncho 4.2/2.2 样本套装K261400Ambu® aScope™ Gastro；Ambu® aScope™ Gastro 大号K260578Ambu® NeurolineTM 杯 MRI/CT（型号 72704/21US，72704/23US，72704/25US，72704/27US）Ambu® NeurolineTM 杯 MRI/CT套装（型号 72704/21-1010US，72704/21-1010US，72704/23-1010US，72704/25-1010US，72704/27-1010US）Ambu® NeurolineTM 杯 MRI/CT迷你套装（型号 72704/21-0301US，72704/23-0301US，72704/25-0301US，72704/27-0301US）K251583Ambu® Virobac II® 呼气过滤器K250269Ambu® aScope™ 5 Cysto HD (标准偏转); Ambu® aScope™ 5 Cysto HD (反向偏转)K240849Ambu® aScope™ 5 Cysto HD (标准偏转); Ambu® aScope™ 5 Cysto HD (反向偏转); Ambu® aBox™ 2
相关器械（代码：CBI）
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。
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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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