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FDA 510(k)

Servo Guard

K-Number: K182862 · 2019-10-21

ApplicantMaquet Critical Care AB
Decision Date2019-10-21
Product CodeCAH
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Servo Guard 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 2019-10-21 under 510(k) number K182862. The device is classified under product code CAH. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Servo Guard?

Servo Guard is a medical device that received FDA 510(k) clearance on 2019-10-21. The listed applicant is Maquet Critical Care AB. The 510(k) number is K182862.

When did Servo Guard receive FDA 510(k) clearance?

Servo Guard received FDA 510(k) clearance on 2019-10-21, under 510(k) number K182862.

Who is the listed applicant for Servo Guard?

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 Guard?

The FDA product code for Servo Guard is CAH.

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

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Related Devices (Code: CAH)

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.

K252643Iso-Gard Filter Straight; Humid-Vent Filter Compact AngledTeleflex Medical Sdn. Bhd.K251583Ambu® Virobac II® Exhalation FilterAmbu A/SK241339Besmed Bacterial Filter and HMEFBesmed Health Business CorpK222917Breathing circuit bacterial/viral filterShaoxing Haitech Medical Products Co., Ltd.K230483Passy Muir Tracheostomy Viral & Bacterial Airway Protection Filter (PM-APF15)Passy-Muir, Inc.K223258TNI Clear-Guard™ 3 angled breathing filter (1545020)Intersurgical , 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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