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FDA 510(k)

Central Monitoring System

K-Number: K153580 · 2016-09-07

ApplicantGuangdong Biolight Meditech Co., Ltd.
Decision Date2016-09-07
Product CodeHGM
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Central Monitoring System is a medical device manufactured by Guangdong Biolight Meditech Co., Ltd.. It received FDA 510(k) clearance on 2016-09-07 under approval number K153580. 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 2016-09-07. It is manufactured by Guangdong Biolight Meditech Co., Ltd.. The 510(k) number is K153580.

When was Central Monitoring System approved by the FDA?

Central Monitoring System received FDA 510(k) clearance on 2016-09-07, under approval number K153580.

What company makes Central Monitoring System?

Central Monitoring System is manufactured by Guangdong Biolight Meditech Co., Ltd..

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 Guangdong Biolight Meditech Co., Ltd.

K160349Electronic Sphygmomanometer K153135VITAL SIGNS MONITOR K152739Electronic Thermometer K151287Fingertip Pulse Oximeters M70, M70A, M70B, M70C, M70D K170514Central Monitoring System K162234Truscope Ultra Patient Monitor

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Related Devices (Code: HGM)

K171178Central Monitoring SystemEdan Instruments, Inc. 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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