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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 the device name listed in this FDA 510(k) record. The listed applicant is Maquet Critica Care AB. It received FDA 510(k) clearance on 2020-06-18 under 510(k) 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. The listed applicant is Maquet Critica Care AB. The 510(k) number is K192604.

When did Servo-air 4.0 Ventilator System receive FDA 510(k) clearance?

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

Who is the listed applicant for Servo-air 4.0 Ventilator System?

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

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 Devices (Code: CBK)

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.

K253647Evita (V800); Evita (V600)Draegerwerk AG & CO KgaaK252663Inbentus VersatileIconic Solutions by Murcia, SLK251888VPAP Pediatric Face MaskHsiner Co., Ltd.K232365Vivo 45 LSOconnell Regulatory Consultants, Inc.K252173F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits – Size A (ONIV117A); F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits – Size B (ONIV117B); F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits – Size C (ONIV117C); F&P OptiNIV ONIV117-F Hospital Vented Full Face Mask with optional Expiratory Filter Compatible with Single-limb Circuits - Size A (ONIV117A-F); F&P OptiNIV ONIV117-F Hospital Vented FullFisher & Paykel Healthcare, Ltd.K243767SV600, SV800 VentilatorShenzhen Mindray Bio-Medical Electronics Co., Ltd.

Official Source

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

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