uMEC12 Patient Monitor
The uMEC12 Patient Monitor measures and displays physiological signals for patients in professional healthcare facilities. Its monitoring functions include ECG, heart and pulse rates,…
The uMEC12 Patient Monitor measures and displays physiological signals for patients in professional healthcare facilities. Its monitoring functions include ECG, heart and pulse rates, respiration, temperature, oxygen saturation and blood pressure. The permitted patient age group depends on the measurement being used.
The monitor presents waveforms and numerical measurements on a 12.1-inch display and uses audible alarms to signal alarm conditions. It can review and transfer monitoring data. It operates from AC power or a rechargeable lithium-ion battery.
Patient Groups
The system supports adult, pediatric and neonatal monitoring, with exceptions. Arrhythmia detection and oxygen saturation are for adults and children; ST analysis and cardiac output are for adults only.
Who Else Makes It
Concentrated in Guangdong (6), Jiangsu (1), Hebei (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 77 |
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
| GE Medical Systems (China) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 57 |
| Edan Instruments, Inc. | Shenzhen | Guangdong | Contract manufacturer | 56 |
| Shenzhen Comen Medical Instruments Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 24 |
| Contec Medical Systems Co., Ltd. | Qinhuangdao | Hebei | Manufacturer | 22 |
| Guangdong Biolight Meditech Co., Ltd. | Zhuhai | Guangdong | Manufacturer | 19 |
| Shanghai Draeger Medical Instrument Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 4 |
| General Meditech, Inc. | Shenzhen | Guangdong | Complaint-file establishment | 3 |
Record
| Listed by | Shenzhen Mindray BIO-Medical Electronics Co., Ltd., China |
|---|---|
| FDA product code | MHX |
| Device type | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1025 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K171901 |
| Record published | 2025-01-24 |
| Record revised | 2026-01-21 (version 2) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| uMEC12 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Fukuda Denshi | Fukuda Denshi Co., Ltd. | 326 |
| Welch Allyn, Inc. | Welch Allyn, Inc. | 266 |
| Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | Nihon Kohden Corp. | 205 |
| Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | Nihon Kohden America, Inc. | 139 |
| Surveyor Central | Mortara Instrument, Inc. | 71 |
| Tempus Pro | Remote Diagnostic Technologies Ltd. | 44 |
| Surveyor S12 | Mortara Instrument, Inc. | 38 |
| Ultraview | Spacelabs Healthcare (Washington), Inc | 29 |
| Surveyor S19 | Mortara Instrument, Inc. | 26 |
| Vital Signs™ | AirLife Finland Oy | 23 |
| Patient Monitor | Edan Instruments, Inc. | 22 |
| Telemetry Accessories | Philips Medizin Systeme Böblingen GmbH | 21 |
Showing 12 of 589. All products under Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K260098 | 2026-05-20 |
| K253170 | 2026-04-16 |
| K213799 | 2022-07-12 |
| K202405 | 2021-01-07 |
| K200015 | 2020-06-08 |
| K192972 | 2020-05-07 |
| K191769 | 2019-10-31 |
| K190011 | 2019-07-10 |
| K182075 | 2018-12-10 |
| K171901 | 2017-11-15 |
| K170876 | 2017-08-23 |
| K153448 | 2016-03-03 |
| K152902 | 2016-02-18 |
| K150082 | 2015-09-02 |
| K150352 | 2015-09-02 |
| K142601 | 2014-11-14 |
| K123074 | 2013-07-03 |
| K092449 | 2010-08-30 |
| K073280 | 2008-06-23 |
| K072346 | 2007-11-29 |
| K070791 | 2007-06-26 |
| K062194 | 2007-04-11 |
| K060281 | 2006-06-23 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.