Fetal Monitor
These fetal monitors track fetal and maternal physiological information during antepartum examinations, labor, and delivery. The range includes F30, F50, F80, and F90 configurations and is…
These fetal monitors track fetal and maternal physiological information during antepartum examinations, labor, and delivery. The range includes F30, F50, F80, and F90 configurations and is intended for use by trained personnel in examination and delivery rooms.
Fetal heart rate is measured using pulsed Doppler ultrasound. Motion of the fetal heart changes the frequency of the reflected sound, allowing the monitor to calculate heart rate. A maternal event counter can record fetal movements felt by the patient.
Clinical Recording
The monitors display, print, and record fetal parameters, including heart rate, uterine activity, and movement. They operate from AC or DC power and are reusable, nonsterile devices. Available maternal monitoring functions depend on the configured model.
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 | Guangdong Biolight Meditech Co., Ltd., China |
|---|---|
| FDA product code | HGM |
| Device type | System, Monitoring, Perinatal |
| Device class | Class 2 |
| Regulation | 21 CFR 884.2740 |
| Establishment | Manufacturer |
| 510(k) | K131941 |
| Record published | 2018-04-09 |
| Record revised | 2022-11-28 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| F50 | In distribution | |
| F90 | In distribution | |
| F80 | In distribution | |
| F30 | 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 |
|---|---|
| K153580 | 2016-09-07 |
| K131941 | 2014-05-15 |
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.