Evita（V800）；Evita（V600）
K号: K253647 · 2026-05-07
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决定日期2026-05-07
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
Evita (V800); Evita (V600) is the device name listed in this FDA 510(k) record. The listed applicant is Draegerwerk AG & CO Kgaa. It received FDA 510(k) clearance on 2026-05-07 under 510(k) number K253647. 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 Evita (V800); Evita (V600)?
Evita (V800); Evita (V600) is a medical device that received FDA 510(k) clearance on 2026-05-07. The listed applicant is Draegerwerk AG & CO Kgaa. The 510(k) number is K253647.
When did Evita (V800); Evita (V600) receive FDA 510(k) clearance?
Evita (V800); Evita (V600) received FDA 510(k) clearance on 2026-05-07, under 510(k) number K253647.
Who is the listed applicant for Evita (V800); Evita (V600)?
The FDA 510(k) record lists Draegerwerk AG & CO Kgaa as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Evita (V800); Evita (V600)?
The FDA product code for Evita (V800); Evita (V600) 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Draegerwerk AG & CO Kgaa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。
K252663Inbentus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.K251133AVEA 可弃用呼出过滤器/水阱 (11790)Telesair, Inc.
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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