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FDA 510(k)

uMEC Series Patient Monitors (including uMEC6, uMEC7, uMEC10, uMEC12, uMEC15, uMEC15S)

K-Number: K171901 · 2017-11-15

ApplicantShenzhen Mindray Bio-Medical Electronics Co., Ltd.
Decision Date2017-11-15
Product CodeMHX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

uMEC Series Patient Monitors (including uMEC6, uMEC7, uMEC10, uMEC12, uMEC15, uMEC15S) is a medical device manufactured by Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. It received FDA 510(k) clearance on 2017-11-15 under approval number K171901. 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 uMEC Series Patient Monitors (including uMEC6, uMEC7, uMEC10, uMEC12, uMEC15, uMEC15S)?

uMEC Series Patient Monitors (including uMEC6, uMEC7, uMEC10, uMEC12, uMEC15, uMEC15S) is a medical device that received FDA 510(k) clearance on 2017-11-15. It is manufactured by Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. The 510(k) number is K171901.

When was uMEC Series Patient Monitors (including uMEC6, uMEC7, uMEC10, uMEC12, uMEC15, uMEC15S) approved by the FDA?

uMEC Series Patient Monitors (including uMEC6, uMEC7, uMEC10, uMEC12, uMEC15, uMEC15S) received FDA 510(k) clearance on 2017-11-15, under approval number K171901.

What company makes uMEC Series Patient Monitors (including uMEC6, uMEC7, uMEC10, uMEC12, uMEC15, uMEC15S)?

uMEC Series Patient Monitors (including uMEC6, uMEC7, uMEC10, uMEC12, uMEC15, uMEC15S) is manufactured by Shenzhen Mindray Bio-Medical Electronics Co., Ltd..

What is the FDA product code for uMEC Series Patient Monitors (including uMEC6, uMEC7, uMEC10, uMEC12, uMEC15, uMEC15S)?

The FDA product code for uMEC Series Patient Monitors (including uMEC6, uMEC7, uMEC10, uMEC12, uMEC15, uMEC15S) is MHX.

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Related PubMed Literature

PMID: 41103840 The Essential Role of Medical Monitors in Clinical Trials. Cureus (2025) PMID: 39707817 Physician-Patient Communication about Novel Drugs and High-Risk Medical Devices. Medical decision making : an international journal of the Society for Medical Decision Making (2025)

Other Devices by Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

K162845DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound System K162267Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound System K161525TE7 Diagnostic Ultrasound, TE5 Diagnostic Ultrasound System K160370BS-800M/ ABS800/BA-800M ISE KIT, BS-800M Chemistry Analyzer, BA-800M Chemistry Analyzer, ABS800 Chemistry Analyzer K160381TE7 Diagnostic Ultrasound System K153448Passport Series Patient Monitors (Including Passport 8, Passport 12)

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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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