LTV2系列呼吸机
K号: K201082 · 2021-11-10
广告
决定日期2021-11-10
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
LTV2 Series Ventilators is the device name listed in this FDA 510(k) record. The listed applicant is Vyaire Medical, Inc.. It received FDA 510(k) clearance on 2021-11-10 under 510(k) number K201082. 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 LTV2 Series Ventilators?
LTV2 Series Ventilators is a medical device that received FDA 510(k) clearance on 2021-11-10. The listed applicant is Vyaire Medical, Inc.. The 510(k) number is K201082.
When did LTV2 Series Ventilators receive FDA 510(k) clearance?
LTV2 Series Ventilators received FDA 510(k) clearance on 2021-11-10, under 510(k) number K201082.
Who is the listed applicant for LTV2 Series Ventilators?
The FDA 510(k) record lists Vyaire Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for LTV2 Series Ventilators?
The FDA product code for LTV2 Series Ventilators 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Vyaire Medical, Inc.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。
广告