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FDA 510(k)

SERVO-U Ventilator System version 2.1; SERVO-n Ventilator System version 2.1

K-Number: K180098 · 2019-03-19

ApplicantMaquet Critical Care AB
Decision Date2019-03-19
Product CodeCBK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

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

When was SERVO-U Ventilator System version 2.1; SERVO-n Ventilator System version 2.1 approved by the FDA?

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

What company makes 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 manufactured by Maquet Critical Care AB.

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.

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Other Devices by Maquet Critical Care AB

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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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