Senbitec Co., Ltd.
South KoreaFDA applicant, unverified
- Devices
- 1
What Senbitec Co., Ltd. makes
Senbitec Co., Ltd. manufactures the HESTIA (L200-A), a medical device designed for [specific application not detailed in data]. This product is intended for [clinical use or purpose not specified, e.g., diagnostic, therapeutic, or monitoring].
The HESTIA (L200-A) falls under Class II regulatory classification and is listed in the FDA’s 510(k) registry. The company is based in the United States.
Catalogue
Hestia (L200-A) Ref K242946
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Senbitec Co., Ltd. have in the registry?
The registry currently lists 1 device for Senbitec Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Senbitec Co., Ltd.'s devices?
Among its 1 most recently registered device, Senbitec Co., Ltd. has devices listed in FDA 510(k) (1 device).
What risk classes do Senbitec Co., Ltd.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Senbitec Co., Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Senbitec Co., Ltd. in the registry?
The most recently registered devices listed for Senbitec Co., Ltd. include HESTIA (L200-A).