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FDA 510(k)

FLOW-i 麻醉系统 C20，FLOW-i 麻醉系统 C30，FLOW-i 麻醉系统 C40

K号: K160665 · 2017-03-29

申请人Maquet Critical Care AB
决定日期2017-03-29
产品代码BSZ
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

FLOW-i Anesthesia System C20, FLOW-i Anesthesia System C30, FLOW-i Anesthesia System C40 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 2017-03-29 under 510(k) number K160665. The device is classified under product code BSZ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the FLOW-i Anesthesia System C20, FLOW-i Anesthesia System C30, FLOW-i Anesthesia System C40?

FLOW-i Anesthesia System C20, FLOW-i Anesthesia System C30, FLOW-i Anesthesia System C40 is a medical device that received FDA 510(k) clearance on 2017-03-29. The listed applicant is Maquet Critical Care AB. The 510(k) number is K160665.

When did FLOW-i Anesthesia System C20, FLOW-i Anesthesia System C30, FLOW-i Anesthesia System C40 receive FDA 510(k) clearance?

FLOW-i Anesthesia System C20, FLOW-i Anesthesia System C30, FLOW-i Anesthesia System C40 received FDA 510(k) clearance on 2017-03-29, under 510(k) number K160665.

Who is the listed applicant for FLOW-i Anesthesia System C20, FLOW-i Anesthesia System C30, FLOW-i Anesthesia System C40?

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 FLOW-i Anesthesia System C20, FLOW-i Anesthesia System C30, FLOW-i Anesthesia System C40?

The FDA product code for FLOW-i Anesthesia System C20, FLOW-i Anesthesia System C30, FLOW-i Anesthesia System C40 is BSZ.

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。

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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 4.1K191027Flow-i 麻醉系统，Flow-c 麻醉系统，Flow-e 麻醉系统K182862Servo GuardK180098SERVO-U 呼吸机系统版本 2.1; SERVO-n 呼吸机系统版本 2.1

查看所有 8 个设备 →

相关器械（代码：BSZ）

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。

K253330A5 麻醉系统（A5）；A7 麻醉系统（A7）Shenzhen Mindray Bio-Medical Electronics Co., Ltd.K252746Atlan (A100); Atlan (A100 XL); Atlan(A350); Atlan (A350 XL)Drägerwerk AG Co. KgaaK251352Codonics安全标签系统-护理点工作站（PCS）（SLS-700i和相关610i、620i、630i系列启用RFID功能）；Codonics安全标签系统-护理点工作站（PCS）（SLS-1，SLS XXX，多个型号待配置）Codonics.IncorporatedK230931AtlanDrägerwerk AG Co. KgaaK213867Carestation 750/750cDatex-Ohmeda, Inc.K201957A8, A9 麻醉系统Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

官方来源

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