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FDA 510(k)

Meridian M110 Fetal Monitoring System

K-Number: K161902 · 2017-01-12

ApplicantMindchild Medical
Decision Date2017-01-12
Product CodeHGM
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Meridian M110 Fetal Monitoring System is a medical device manufactured by Mindchild Medical. It received FDA 510(k) clearance on 2017-01-12 under approval number K161902. The device is classified under product code HGM. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Meridian M110 Fetal Monitoring System?

Meridian M110 Fetal Monitoring System is a medical device that received FDA 510(k) clearance on 2017-01-12. It is manufactured by Mindchild Medical. The 510(k) number is K161902.

When was Meridian M110 Fetal Monitoring System approved by the FDA?

Meridian M110 Fetal Monitoring System received FDA 510(k) clearance on 2017-01-12, under approval number K161902.

What company makes Meridian M110 Fetal Monitoring System?

Meridian M110 Fetal Monitoring System is manufactured by Mindchild Medical.

What is the FDA product code for Meridian M110 Fetal Monitoring System?

The FDA product code for Meridian M110 Fetal Monitoring System is HGM.

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Related PubMed Literature

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Related Devices (Code: HGM)

K153580Central Monitoring SystemGuangdong Biolight Meditech Co., Ltd. K171178Central Monitoring SystemEdan Instruments, Inc. K171865F1 Mothership Wireless Transducers for Fetal Ultrasonic and Tocodynamometer MonitoringFarus, LLC K173941IntelliSpace Perinatal Rev.K.00Philips Medizin Systeme Boeblingen GmbH K173042Fetal & Maternal Monitor: Models F6, F6 Express, F9, F9 Express; Fetal Monitor: Models F2, F3Edan Instruments, Inc. K173715AlertWatch:OBAlertwatch, Inc.

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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