Patient Monitor M30
The Mediana Lucon M30 is a compact patient monitor for adult, pediatric and neonatal care in hospitals and similar clinical facilities. It displays physiological measurements and monitoring…
The Mediana Lucon M30 is a compact patient monitor for adult, pediatric and neonatal care in hospitals and similar clinical facilities. It displays physiological measurements and monitoring status on a TFT LCD screen.
The monitor measures ECG, heart rate, noninvasive blood pressure, oxygen saturation, pulse rate, respiration and temperature. The M30 also provides arrhythmia and ST segment monitoring and capnography, features that distinguish it from the M20 model.
Listed Item
The M30 is intended to be used to monitor electrocardiography (ECG), heart rate (HR), noninvasive blood pressure (NIBP) – systolic, diastolic and mean arterial pressures, functional arterial oxygen saturation (SpO2), pulse rate (PR), respiration rate (RR), capnography (EtCO2 and InCO2) temperature (Temp) for adult, pediatric and neonatal patients in all areas of a hospital and hospital-type facilities. Monitor users should be skilled at the level of a technician, doctor, nurse or medical specialist. The M30 is suitable for continuous operation.
Power and Operation
The device can run from mains power or an internal battery. It is intended for trained users who can select and adjust monitor settings, including alarm limits and notifications, in areas such as general care, operating rooms and critical care.
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 | Mediana Co., Ltd., South Korea |
|---|---|
| FDA product code | MHX |
| Device type | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1025 |
| Establishment | Contract manufacturer, Manufacturer |
| 510(k) | K100217 |
| Record published | 2019-08-08 |
| Record revised | 2021-11-10 (version 4) |
Specifications
| MRI safety | MR Safe |
|---|---|
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | manufacturing date, serial number |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| M30 | In distribution | |
| M30 | In distribution | |
| M30 | 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 |
|---|---|
| K112190 | 2011-11-09 |
| K100217 | 2010-06-08 |
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.