Amt Engineering Co., Ltd.
South KoreaFDA applicant, unverified FDA FEI 3010902869
- Devices
- 2
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA FEI
What Amt Engineering Co., Ltd. makes
Amt Engineering Co., Ltd. manufactures the Lucas Plus, a device designed for mechanical ventilation support, and the COPRO 3, a portable respiratory assist system for patients requiring non-invasive ventilation.
These products are classified as Class II medical devices and are listed under the FDA’s 510(k) pathway. The company is based in the United States.
Catalogue
Lucas Plus Ref K230340
Regimes: 510(k) Registry: 510(k)Copro 3 Ref K241672
Regimes: 510(k) Registry: 510(k)
Company details
- FDA FEI number
- 3010902869
- Address
- #811 Byoksan Technopia, Seongnam-si Gyeonggi
Frequently asked questions
How many devices does Amt Engineering Co., Ltd. have in the registry?
The registry currently lists 2 devices for Amt Engineering Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Amt Engineering Co., Ltd.'s devices?
Among its 2 most recently registered devices, Amt Engineering Co., Ltd. has devices listed in FDA 510(k) (2 devices).
What risk classes do Amt Engineering Co., Ltd.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Amt Engineering Co., Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Amt Engineering Co., Ltd. in the registry?
The most recently registered devices listed for Amt Engineering Co., Ltd. include Lucas Plus and COPRO 3.