Hayashi Denki Co., Ltd.
Country not established
- Devices
- 1
What Hayashi Denki Co., Ltd. makes
Hayashi Denki Co., Ltd. manufactures the MINI-DOPPLER ES-100, a handheld Doppler ultrasound device used for non-invasive blood flow monitoring and fetal heart rate assessment in clinical settings.
The MINI-DOPPLER ES-100 is classified as a Class II medical device in the US and is listed under the FDA’s 510(k) pathway. The company is based in the United States.
Catalogue
Mini-Doppler Es-100 Ref K840542
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Hayashi Denki Co., Ltd. have in the registry?
The registry currently lists 1 device for Hayashi Denki Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Hayashi Denki Co., Ltd.'s devices?
Among its 1 most recently registered device, Hayashi Denki Co., Ltd. has devices listed in FDA 510(k) (1 device).
What risk classes do Hayashi Denki Co., Ltd.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Hayashi Denki Co., Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Hayashi Denki Co., Ltd. in the registry?
The most recently registered devices listed for Hayashi Denki Co., Ltd. include MINI-DOPPLER ES-100.