Incubator, Neonatal
The BT-500 infant incubator maintains a warm environment for premature and newborn infants who cannot regulate their own body temperature. It supplies controlled heat and air within a hood…
The BT-500 infant incubator maintains a warm environment for premature and newborn infants who cannot regulate their own body temperature. It supplies controlled heat and air within a hood for care, observation and examination in newborn nurseries. It is not intended for transport.
Sensors monitor humidity and temperature inside the hood, while a heater and controlled air circulation maintain the selected environment. A skin probe measures the infant’s temperature and supports control of heating to keep it at the set level. The incubator includes a control box and external LCD monitor.
Listed Item
BT-500 Infant incubator consists of Hood, Control Box, LCD external monitor and main body with stand ( optional), This device incorporates two sensors to control Humidity, and Temperature inside the Hood and monitors the Air Conditions, and controls Circulation with proper temperature.
Monitoring
The display measures and graphs humidity, air temperature and skin temperature, along with weight and oxygen saturation. These monitored values allow staff to observe changes while the infant remains within the controlled incubator environment.
Who Else Makes It
All of them in Jiangsu. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol (Changzhou) Connector Systems Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 4 |
| GE Medical Systems (China) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 57 |
Record
| Listed by | Bistos Co., Ltd., South Korea |
|---|---|
| FDA product code | FMZ |
| Device type | Incubator, Neonatal |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5400 |
| Establishment | Contract manufacturer, Complaint-file establishment, Manufacturer |
| 510(k) | K132543 |
| Record published | 2016-06-03 |
| Record revised | 2018-07-06 (version 4) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Storage environment humidity 0 to 95 % RH; Handling environment temperature 20 to 30 °C; Handling environment humidity 0 to 95 % RH; Storage environment temperature -20 to 60 °C |
| Packaging | Carton box |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| BT-500 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Tarry Probes | Tarry Medical Products, Inc. | 7 |
| Midas Rex MR8 | Medtronic Powered Surgical Solutions | 6 |
| Airlife | AirLife Finland Oy | 6 |
| AirLife | Carefusion Finland 320 Oy | 5 |
| Multi-Link™ | AirLife Finland Oy | 3 |
| Access Medical Probes | Tarry Medical Products, Inc. | 3 |
| Advanced Neonatal Incubator | Advanced Instrumentations, Inc. | 2 |
| Babyleo TN500 | Drägerwerk AG & Co. KGaA | 2 |
| Isolette® 8000 plus | Draeger Medical Systems, Inc. | 2 |
| Isolette 8000 Infant Incubator | Draeger Medical Systems, Inc. | 1 |
| Skin Temp Probe, 5mm O.D.(Y) | Atom Medical Corporation | 1 |
| Oxygen Sensor For Dual Incu i, Incu i, V-2200/2100G(2 pcs/set) | Atom Medical Corporation | 1 |
Showing 12 of 41. All products under Incubator, Neonatal
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K132543 | 2014-07-03 |
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.