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FDA 510(k)

Servo-air 4.0 Ventilator System

K-Number: K192604 · 2020-06-18

ApplicantMaquet Critica Care AB
Decision Date2020-06-18
Product CodeCBK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Servo-air 4.0 Ventilator System is a medical device manufactured by Maquet Critica Care AB. It received FDA 510(k) clearance on 2020-06-18 under approval number K192604. 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-air 4.0 Ventilator System?

Servo-air 4.0 Ventilator System is a medical device that received FDA 510(k) clearance on 2020-06-18. It is manufactured by Maquet Critica Care AB. The 510(k) number is K192604.

When was Servo-air 4.0 Ventilator System approved by the FDA?

Servo-air 4.0 Ventilator System received FDA 510(k) clearance on 2020-06-18, under approval number K192604.

What company makes Servo-air 4.0 Ventilator System?

Servo-air 4.0 Ventilator System is manufactured by Maquet Critica Care AB.

What is the FDA product code for Servo-air 4.0 Ventilator System?

The FDA product code for Servo-air 4.0 Ventilator System 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

Related Devices (Code: CBK)

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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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