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FDA 510(k)

Central Monitoring System

K-Number: K170514 · 2017-05-24

ApplicantGuangdong Biolight Meditech Co., Ltd.
Decision Date2017-05-24
Product CodeMHX
Advisory CommitteeCV
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 2017-05-24 under approval number K170514. The device is classified under product code MHX. It was reviewed by the CV 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 2017-05-24. It is manufactured by Guangdong Biolight Meditech Co., Ltd.. The 510(k) number is K170514.

When was Central Monitoring System approved by the FDA?

Central Monitoring System received FDA 510(k) clearance on 2017-05-24, under approval number K170514.

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 MHX.

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Related PubMed Literature

PMID: 37306642 Regulatory Framework for Implantable Neurostimulation Devices: Comparison of Systems in the US and European Union. Neuromodulation : journal of the International Neuromodulation Society (2024) PMID: 37181834 Methodology for Conducting Post-Marketing Surveillance of Software as a Medical Device Based on Artificial Intelligence Technologies. Sovremennye tekhnologii v meditsine (2022) PMID: 29988408 Regulation of Neurological Devices and Neurointerventional Endovascular Approaches for Acute Ischemic Stroke. Frontiers in neurology (2018)

Other Devices by Guangdong Biolight Meditech Co., Ltd.

K160349Electronic Sphygmomanometer K153580Central Monitoring System K153135VITAL SIGNS MONITOR K152739Electronic Thermometer K151287Fingertip Pulse Oximeters M70, M70A, M70B, M70C, M70D K162234Truscope Ultra Patient Monitor

View all 8 devices →

Related Devices (Code: MHX)

K160981Patient MonitorEdan Instruments, Inc. K153707Nihon Kohden Vital Sign TelemeterNihon Kohden Corporation K160685Surveyor S4 Mobile MonitorMortara Instrument, Inc. K161531IntelliVue Patient Monitors MP2, MP5, MP5T, MP5SC, and Multi-Measurement Module X2; IntelliVue Patient Monitors MP20, MP30, MP40, MP50, MP60; IntelliVue Patient Monitors MP70, MP80, MP90;IntelliVue Patient Monitors MX400, MX430, MX450, MX500, MX550, MX600;IntelliVue Patient Monitors MX700, MX800Philips Medizin Systeme Boeblingen GmbH K153702M3290B Philips IntelliVue Information Center iXPhilips Medical Systems K160951Philips Efficia CMS200 Central Monitoring SystemPhilips Medical Systems

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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