Hi-Bebe
BT-200 is a pocket-size fetal Monitor that measures the fetal heat rate and outputs the fetal heart sound through built-in speaker.
6manufacturers in China registered for this device type
3catalogue numbers in this listing
5510(k) clearances naming this product code
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 | Bistos Co., Ltd., South Korea |
|---|---|
| FDA product code | HGM |
| Device type | System, Monitoring, Perinatal |
| Device class | Class 2 |
| Regulation | 21 CFR 884.2740 |
| Establishment | Contract manufacturer, Complaint-file establishment, Manufacturer |
| 510(k) | K052190 |
| Record published | 2018-03-16 |
| Record revised | 2022-11-28 (version 5) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Storage environment temperature -20 to 60 °C; Storage environment humidity 0 to 95 % RH; Handling environment humidity 5 to 85 % RH; Handling environment temperature 10 to 40 °C |
| Packaging | Gift box, carton box of 20, carton box of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| BT-200C | In distribution | |
| BT-200S | In distribution | |
| BT-200L | 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 |
|---|---|
| K142799 | 2015-07-09 |
| K121267 | 2012-08-02 |
| K103545 | 2011-05-13 |
| K100885 | 2010-06-07 |
| K052190 | 2005-10-04 |
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.