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FDA 510(k)

uMEC 60/ uMEC 70/ uMEC 80/uMEC 100/uMEC 120/uMEC 150 Patient Monitors

K-Number: K253170 · 2026-04-16

ApplicantShenzhen Mindray Bio-Medical Electronics Co., Ltd.
Decision Date2026-04-16
Product CodeMHX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

uMEC 60/ uMEC 70/ uMEC 80/uMEC 100/uMEC 120/uMEC 150 Patient Monitors is a medical device manufactured by Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. It received FDA 510(k) clearance on 2026-04-16 under approval number K253170. 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 60/ uMEC 70/ uMEC 80/uMEC 100/uMEC 120/uMEC 150 Patient Monitors?

uMEC 60/ uMEC 70/ uMEC 80/uMEC 100/uMEC 120/uMEC 150 Patient Monitors is a medical device that received FDA 510(k) clearance on 2026-04-16. It is manufactured by Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. The 510(k) number is K253170.

When was uMEC 60/ uMEC 70/ uMEC 80/uMEC 100/uMEC 120/uMEC 150 Patient Monitors approved by the FDA?

uMEC 60/ uMEC 70/ uMEC 80/uMEC 100/uMEC 120/uMEC 150 Patient Monitors received FDA 510(k) clearance on 2026-04-16, under approval number K253170.

What company makes uMEC 60/ uMEC 70/ uMEC 80/uMEC 100/uMEC 120/uMEC 150 Patient Monitors?

uMEC 60/ uMEC 70/ uMEC 80/uMEC 100/uMEC 120/uMEC 150 Patient Monitors is manufactured by Shenzhen Mindray Bio-Medical Electronics Co., Ltd..

What is the FDA product code for uMEC 60/ uMEC 70/ uMEC 80/uMEC 100/uMEC 120/uMEC 150 Patient Monitors?

The FDA product code for uMEC 60/ uMEC 70/ uMEC 80/uMEC 100/uMEC 120/uMEC 150 Patient Monitors is MHX.

Related Clinical Trials

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Related PubMed Literature

PMID: 41103840 The Essential Role of Medical Monitors in Clinical Trials. Cureus (2025)

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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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