FDA 510(k)

Servo Guard

K号: K182862 · 2019-10-21

决定日期2019-10-21

产品代码CAH

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决定实质等同

器械摘要

Servo Guard 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 2019-10-21 under 510(k) number K182862. The device is classified under product code CAH. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Servo Guard?

Servo Guard is a medical device that received FDA 510(k) clearance on 2019-10-21. The listed applicant is Maquet Critical Care AB. The 510(k) number is K182862.

When did Servo Guard receive FDA 510(k) clearance?

Servo Guard received FDA 510(k) clearance on 2019-10-21, under 510(k) number K182862.

Who is the listed applicant for Servo Guard?

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 Guard?

The FDA product code for Servo Guard is CAH.

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)K230173Servo-air Lite呼吸机系统 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 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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