Ime Co., Ltd.
Country not established
- Devices
- 2
What Ime Co., Ltd. makes
Ime Co., Ltd. manufactures the HR-5000 Electrosurgical Device, including a version for an expanded indication. These devices are designed for controlled tissue cutting and coagulation in surgical procedures.
The HR-5000 Electrosurgical Device is classified as Class I under FDA regulations and is listed via the 510(k) pathway. The company is based in the United States.
Catalogue
Hr-5000 Electrosurgical Device Ref K864869
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Ime Co., Ltd. have in the registry?
The registry currently lists 2 devices for Ime Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Ime Co., Ltd.'s devices?
Among its 2 most recently registered devices, Ime Co., Ltd. has devices listed in FDA 510(k) (2 devices).
What risk classes do Ime Co., Ltd.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Ime Co., Ltd.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Ime Co., Ltd. in the registry?
The most recently registered devices listed for Ime Co., Ltd. include HR-5000 ELECTROSURGICAL DEVICE and HR-5000 ELECTROSURGICAL DEVICE FOR NEW INDICATIONS.