温图斯 VC2；温图斯 VC3
K号: K223120 · 2024-12-02
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决定日期2024-12-02
产品代码CBK
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
Ventoux VC2; Ventoux VC3 is the device name listed in this FDA 510(k) record. The listed applicant is Flight Medical Innovations , Ltd.. It received FDA 510(k) clearance on 2024-12-02 under 510(k) number K223120. The device is classified under product code CBK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Ventoux VC2; Ventoux VC3?
Ventoux VC2; Ventoux VC3 is a medical device that received FDA 510(k) clearance on 2024-12-02. The listed applicant is Flight Medical Innovations , Ltd.. The 510(k) number is K223120.
When did Ventoux VC2; Ventoux VC3 receive FDA 510(k) clearance?
Ventoux VC2; Ventoux VC3 received FDA 510(k) clearance on 2024-12-02, under 510(k) number K223120.
Who is the listed applicant for Ventoux VC2; Ventoux VC3?
The FDA 510(k) record lists Flight Medical Innovations , Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Ventoux VC2; Ventoux VC3?
The FDA product code for Ventoux VC2; Ventoux VC3 is CBK.
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Flight Medical Innovations , 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：CBK）
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。
K253647Evita（V800）；Evita（V600）Draegerwerk AG & CO KgaaK252663Inbentus多用途Iconic Solutions by Murcia, SLK251888VPAP儿童面罩Hsiner Co., Ltd.K232365Vivo 45 LSOconnell Regulatory Consultants, Inc.K252173F&P OptiNIV医院通气全脸面罩与单肢电路兼容 - 尺寸A (ONIV117A)；F&P OptiNIV医院通气全脸面罩与单肢电路兼容 - 尺寸B (ONIV117B)；F&P OptiNIV医院通气全脸面罩与单肢电路兼容 - 尺寸C (ONIV117C)；F&P OptiNIV ONIV117-F医院通气全脸面罩带可选呼气过滤器与单肢电路兼容 - 尺寸A (ONIV117A-F)；F&P OptiNIV ONIV117-F医院通气全脸面罩Fisher & Paykel Healthcare, Ltd.K243767SV600, SV800 VentilatorShenzhen Mindray Bio-Medical Electronics Co., Ltd.
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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