FDA 510(k)

Servo-air Lite呼吸机系统

K号: K230173 · 2023-07-06

决定日期2023-07-06

产品代码MNT

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决定实质等同

器械摘要

Servo-air Lite Ventilator System is the device name listed in this FDA 510(k) record. The listed applicant is Maquet Critical Care AB. It received FDA 510(k) clearance on 2023-07-06 under 510(k) number K230173. The device is classified under product code MNT. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Servo-air Lite Ventilator System?

Servo-air Lite Ventilator System is a medical device that received FDA 510(k) clearance on 2023-07-06. The listed applicant is Maquet Critical Care AB. The 510(k) number is K230173.

When did Servo-air Lite Ventilator System receive FDA 510(k) clearance?

Servo-air Lite Ventilator System received FDA 510(k) clearance on 2023-07-06, under 510(k) number K230173.

Who is the listed applicant for Servo-air Lite Ventilator System?

FDA 510(k)记录显示Maquet Critical Care AB为申请人。这本身并不能确立该设备制造商的身份。

What is the FDA product code for Servo-air Lite Ventilator System?

The FDA product code for Servo-air Lite Ventilator System is MNT.

列明Maquet Critical Care AB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。

K253715Edi 导管 ENFit 6Fr/48 cm (6893166)；Edi 导管 ENFit 6Fr/49cm (6893273)；Edi 导管 ENFit 6Fr/50cm (6893274)；Edi 导管 ENFit 8Fr/50cm (6893275)；Edi 导管 ENFit 8Fr/100cm (6893276)；Edi 导管 ENFit 8Fr/125cm (6893277)；Edi 导管 ENFit 12Fr/125cm (6893278)；Edi 导管 ENFit 16Fr/125cm (6893279)K201874Servo-u 呼吸机系统 4.1，Servo-n 呼吸机系统 4.1，Servo-u MR 呼吸机系统 4.1 K191027Flow-i 麻醉系统，Flow-c 麻醉系统，Flow-e 麻醉系统 K182862Servo Guard K180098SERVO-U 呼吸机系统版本 2.1; SERVO-n 呼吸机系统版本 2.1 K160665FLOW-i 麻醉系统 C20，FLOW-i 麻醉系统 C30，FLOW-i 麻醉系统 C40

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官方来源

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