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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 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 2023-07-06 under 510(k) 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. The listed applicant is Maquet Critical Care AB. The 510(k) number is K230173.

When did Servo-air Lite Ventilator System receive FDA 510(k) clearance?

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

Who is the listed applicant for Servo-air Lite Ventilator System?

The FDA 510(k) record lists Maquet Critical Care AB as the applicant. This does not by itself establish the device manufacturer.

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

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT06114992Servo-n HFOV Study: Safety and Performance in Neonates and InfantsCOMPLETED

Other records listing Maquet Critical Care AB as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K201874Servo-u Ventilator System 4.1, Servo-n Ventilator System 4.1, Servo-u MR Ventilator System 4.1K191027Flow-i Anesthesia System, Flow-c Anesthesia System, Flow-e Anesthesia SystemK182862Servo GuardK180098SERVO-U Ventilator System version 2.1; SERVO-n Ventilator System version 2.1K160665FLOW-i Anesthesia System C20, FLOW-i Anesthesia System C30, FLOW-i Anesthesia System C40K153688Edi Catheter ENFit

View all 7 devices →

Related Devices (Code: MNT)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252182SV70 Ventilator (SV70)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.K242931HFT750UMekics Co., Ltd.K240779Vivo 3Breas Medical ABK233643F&P Airvo 3 NIV (PT311US)Fisher & Paykel Healthcare, Ltd.K213521Nihon Kohden NKV-330 Ventilator SystemNihon Kohden Orangemed, Inc.K191624F&P Nivairo RT047 Vented Hospital Full Face Mask, Anti-Asphyxiation Valve VersionFisher & Paykel Healthcare Limited

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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