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FDA 510(k)

Servo-u Ventilator System 4.1, Servo-n Ventilator System 4.1, Servo-u MR Ventilator System 4.1

K-Number: K201874 · 2021-04-20

ApplicantMaquet Critical Care AB
Decision Date2021-04-20
Product CodeCBK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Servo-u Ventilator System 4.1, Servo-n Ventilator System 4.1, Servo-u MR Ventilator System 4.1 is a medical device manufactured by Maquet Critical Care AB. It received FDA 510(k) clearance on 2021-04-20 under approval number K201874. The device is classified under product code CBK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Servo-u Ventilator System 4.1, Servo-n Ventilator System 4.1, Servo-u MR Ventilator System 4.1?

Servo-u Ventilator System 4.1, Servo-n Ventilator System 4.1, Servo-u MR Ventilator System 4.1 is a medical device that received FDA 510(k) clearance on 2021-04-20. It is manufactured by Maquet Critical Care AB. The 510(k) number is K201874.

When was Servo-u Ventilator System 4.1, Servo-n Ventilator System 4.1, Servo-u MR Ventilator System 4.1 approved by the FDA?

Servo-u Ventilator System 4.1, Servo-n Ventilator System 4.1, Servo-u MR Ventilator System 4.1 received FDA 510(k) clearance on 2021-04-20, under approval number K201874.

What company makes Servo-u Ventilator System 4.1, Servo-n Ventilator System 4.1, Servo-u MR Ventilator System 4.1?

Servo-u Ventilator System 4.1, Servo-n Ventilator System 4.1, Servo-u MR Ventilator System 4.1 is manufactured by Maquet Critical Care AB.

What is the FDA product code for Servo-u Ventilator System 4.1, Servo-n Ventilator System 4.1, Servo-u MR Ventilator System 4.1?

The FDA product code for Servo-u Ventilator System 4.1, Servo-n Ventilator System 4.1, Servo-u MR Ventilator System 4.1 is CBK.

Related Clinical Trials

NCT07585019 Ventilator Study in the NICU NOT_YET_RECRUITING NCT06114992 Servo-n HFOV Study: Safety and Performance in Neonates and Infants ACTIVE_NOT_RECRUITING NCT06595602 Intelligent Lung Support in the Intensive Care Unit RECRUITING

Other Devices by Maquet Critical Care AB

K160665FLOW-i Anesthesia System C20, FLOW-i Anesthesia System C30, FLOW-i Anesthesia System C40 K153688Edi Catheter ENFit K182862Servo Guard K180098SERVO-U Ventilator System version 2.1; SERVO-n Ventilator System version 2.1 K191027Flow-i Anesthesia System, Flow-c Anesthesia System, Flow-e Anesthesia System K230173Servo-air Lite Ventilator System

View all 7 devices →

Related Devices (Code: CBK)

K153046HAMILTON-MR1Hamilton Medical AG K152068Astral 100/150Resmed, Ltd. K143035Flight 60 VentilatorFlight Medical Innovations , Ltd. K151252Puritan Bennett 840 Series Ventilator SystemCovidien LP K162738Puritan Bennett 980 Ventilator SystemCovidien K170037Breathe Technologies Life2000™ Ventilation SystemBreathe Technologies

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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