Biosys Co., Ltd.
Country not established
- Devices
- 1
What Biosys Co., Ltd. makes
Biosys Co., Ltd. manufactures the BIOSYS FETAL MONITOR (Model IFM-500), a device designed for real-time fetal heart rate monitoring during pregnancy.
The fetal monitor is classified as a Class II medical device in the U.S. and is listed under the FDA’s 510(k) pathway. The company is based in the United States.
Catalogue
Biosys Fetal Monitor, Model Ifm-500 Ref K994008
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Biosys Co., Ltd. have in the registry?
The registry currently lists 1 device for Biosys Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Biosys Co., Ltd.'s devices?
Among its 1 most recently registered device, Biosys Co., Ltd. has devices listed in FDA 510(k) (1 device).
What risk classes do Biosys Co., Ltd.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Biosys Co., Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Biosys Co., Ltd. in the registry?
The most recently registered devices listed for Biosys Co., Ltd. include BIOSYS FETAL MONITOR, MODEL IFM-500.