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FDA 510(k)

Servo-air Lite Ventilator System

K-Number: K230173 · 2023-07-06

ApplicantMaquet Critical Care AB
Decision Date2023-07-06
Product CodeMNT
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Servo-air Lite Ventilator System is a medical device manufactured by Maquet Critical Care AB. It received FDA 510(k) clearance on 2023-07-06 under approval number K230173. The device is classified under product code MNT. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Servo-air Lite Ventilator System?

Servo-air Lite Ventilator System is a medical device that received FDA 510(k) clearance on 2023-07-06. It is manufactured by Maquet Critical Care AB. The 510(k) number is K230173.

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

Servo-air Lite Ventilator System received FDA 510(k) clearance on 2023-07-06, under approval number K230173.

What company makes Servo-air Lite Ventilator System?

Servo-air Lite Ventilator System is manufactured by Maquet Critical Care AB.

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

The FDA product code for Servo-air Lite Ventilator System is MNT.

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 K201874Servo-u Ventilator System 4.1, Servo-n Ventilator System 4.1, Servo-u MR Ventilator System 4.1

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Related Devices (Code: MNT)

K170367Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Large, Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Medium, Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Small, Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Extra SmallFisher and Paykel Healthcare Limited K191624F&P Nivairo RT047 Vented Hospital Full Face Mask, Anti-Asphyxiation Valve VersionFisher & Paykel Healthcare Limited K213521Nihon Kohden NKV-330 Ventilator SystemNihon Kohden Orangemed, Inc. K240779Vivo 3Breas Medical AB K233643F&P Airvo 3 NIV (PT311US)Fisher & Paykel Healthcare, Ltd. K242931HFT750UMekics Co., Ltd.

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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