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FDA 510(k)

Central Monitoring System

K-Number: K171178 · 2017-09-06

ApplicantEdan Instruments, Inc.
Decision Date2017-09-06
Product CodeHGM
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Central Monitoring System is a medical device manufactured by Edan Instruments, Inc.. It received FDA 510(k) clearance on 2017-09-06 under approval number K171178. 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 Central Monitoring System?

Central Monitoring System is a medical device that received FDA 510(k) clearance on 2017-09-06. It is manufactured by Edan Instruments, Inc.. The 510(k) number is K171178.

When was Central Monitoring System approved by the FDA?

Central Monitoring System received FDA 510(k) clearance on 2017-09-06, under approval number K171178.

What company makes Central Monitoring System?

Central Monitoring System is manufactured by Edan Instruments, Inc..

What is the FDA product code for Central Monitoring System?

The FDA product code for Central Monitoring System is HGM.

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Related PubMed Literature

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Other Devices by Edan Instruments, Inc.

K160981Patient Monitor K151978EDAN i15 Blood Gas and Chemistry Analysis System, EDAN i15 Calibrant Fluid Pack, EDAN i15 Blood Gas and Electrolyte Control, EDAN i15 Hematocrit Control K161302PC ECG K161300Acclarix AX8 Diagnostic Ultrasound System K152552Patient Monitor K160790Acclarix LX8 Diagnostic Ultrasound System

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Related Devices (Code: HGM)

K153580Central Monitoring SystemGuangdong Biolight Meditech Co., Ltd. K171865F1 Mothership Wireless Transducers for Fetal Ultrasonic and Tocodynamometer MonitoringFarus, LLC K161902Meridian M110 Fetal Monitoring SystemMindchild Medical 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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