FDA 510(k)

SERVO-U 呼吸器系統版本 2.1；SERVO-n 呼吸器系統版本 2.1

K 號：K180098 · 2019-03-19

決定日期2019-03-19

產品代碼CBK

諮詢委員會AN

決定相當於

器材摘要

SERVO-U Ventilator System version 2.1; SERVO-n Ventilator System version 2.1 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 2019-03-19 under 510(k) number K180098. The device is classified under product code CBK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the SERVO-U Ventilator System version 2.1; SERVO-n Ventilator System version 2.1?

SERVO-U Ventilator System version 2.1; SERVO-n Ventilator System version 2.1 is a medical device that received FDA 510(k) clearance on 2019-03-19. The listed applicant is Maquet Critical Care AB. The 510(k) number is K180098.

When did SERVO-U Ventilator System version 2.1; SERVO-n Ventilator System version 2.1 receive FDA 510(k) clearance?

SERVO-U Ventilator System version 2.1; SERVO-n Ventilator System version 2.1 received FDA 510(k) clearance on 2019-03-19, under 510(k) number K180098.

Who is the listed applicant for SERVO-U Ventilator System version 2.1; SERVO-n Ventilator System version 2.1?

FDA 510(k) 記錄將 Maquet Critical Care AB 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for SERVO-U Ventilator System version 2.1; SERVO-n Ventilator System version 2.1?

The FDA product code for SERVO-U Ventilator System version 2.1; SERVO-n Ventilator System version 2.1 is CBK.

其他以 Maquet Critical Care AB 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K253715Edi 尿管 ENFit 6Fr/48 cm (6893166)；Edi 尿管 ENFit 6Fr/49cm (6893273)；Edi 尿管 ENFit 6Fr/50cm (6893274)；Edi 尿管 ENFit 8Fr/50cm (6893275)；Edi 尿管 ENFit 8Fr/100cm (6893276)；Edi 尿管 ENFit 8Fr/125cm (6893277)；Edi 尿管 ENFit 12Fr/125cm (6893278)；Edi 尿管 ENFit 16Fr/125cm (6893279)K230173伺服空氣輕型呼吸器系統 K201874伺服-u 呼吸器系統 4.1、伺服-n 呼吸器系統 4.1、伺服-u MR 呼吸器系統 4.1 K191027Flow-i 麻醉系統，Flow-c 麻醉系統，Flow-e 麻醉系統 K182862伺服保護器 K160665FLOW-i 麻醉系統 C20，FLOW-i 麻醉系統 C30，FLOW-i 麻醉系統 C40

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相關器械（代碼：CBK）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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官方來源

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