Advanced Central Monitoring Station
The Advanced CMS-1000FM Central Monitoring Station manages perinatal monitoring data before and during labour in healthcare facilities. It brings data from bedside fetal and maternal…
The Advanced CMS-1000FM Central Monitoring Station manages perinatal monitoring data before and during labour in healthcare facilities. It brings data from bedside fetal and maternal monitors, together with manually entered information, to a central nursing station and creates an electronic record.
The software runs on a computer and connects to as many as 32 bedside monitors by Ethernet. It can show multiple monitors together or one in full screen. Audible and visual alarms indicate values outside user-set limits or poor signal quality.
Records and Reports
The station displays fetal heart rate, uterine activity and maternal vital signs. Users can review saved records and print cardiotocography, vital-sign and blood-pressure reports. Patient information and monitoring records can also be saved for backup.
Who Else Makes It
Concentrated in Guangdong (4), Jiangsu (1), Shandong (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 77 |
| Luen Hing Textile -Shangyu Manufacturing(ZHONG Shan) Co Ltd | Zhongshan | Guangdong | Contract manufacturer | 2 |
| GE Medical Systems (China) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 57 |
| Edan Instruments, Inc. | Shenzhen | Guangdong | Contract manufacturer | 56 |
| Orantech Inc. | Shenzhen | Guangdong | Contract manufacturer | 40 |
| China Qingdao Bright Medical Manufacturing Co., Ltd. | Qingdao | Shandong | Contract manufacturer | 8 |
Record
| Listed by | Advanced Instrumentations, Inc., United States |
|---|---|
| FDA product code | HGM |
| Device type | System, Monitoring, Perinatal |
| Device class | Class 2 |
| Regulation | 21 CFR 884.2740 |
| Establishment | Specification developer, Manufacturer, Exporter |
| 510(k) | K112159 |
| Record published | 2020-04-17 |
| Record revised | 2020-05-19 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
| Distribution end date | 2028-04-15 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CMS-1000FM | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| R&D Batteries, Inc. | R & D Batteries, Inc. | 137 |
| Sonicaid | Huntleigh Healthcare Ltd. | 39 |
| Obix | Huntleigh Healthcare Ltd. | 33 |
| Ameritus Transducer | Kentec Medical, LLC | 28 |
| Fetal Monitor Remote Display | Clinicomp Intl., Inc. | 18 |
| Tenacore | Tenacore LLC | 11 |
| FetaLink | Cerner Corporation | 9 |
| PeriWatch Vigilance® HUB™ | PeriGen Solutions Ltd. | 9 |
| Dopplex | Huntleigh Healthcare Ltd. | 9 |
| Mini Telemetry System | Wipro GE Healthcare Private Ltd. | 8 |
| Natus Neurology | Natus Neurology Incorporated | 8 |
| Fetal & maternal monitor | Edan Instruments, Inc. | 8 |
Showing 12 of 117. All products under System, Monitoring, Perinatal
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K141194 | 2014-11-19 |
| K112317 | 2011-12-21 |
| K112159 | 2011-09-21 |
| K112187 | 2011-09-21 |
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.