Amcg Co., Ltd.
South KoreaFDA applicant, unverified
- Devices
- 1
What Amcg Co., Ltd. makes
Amcg Co., Ltd. manufactures the MCG-S (AM1000), a medical device designed for cardiac monitoring and electrophysiological studies, enabling precise measurement of cardiac electrical activity.
The device falls under FDA Class II regulation and is listed via the 510(k) clearance pathway. The company is based in the United States.
Catalogue
Mcg-S (AM1000) Ref K232823
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Amcg Co., Ltd. have in the registry?
The registry currently lists 1 device for Amcg Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Amcg Co., Ltd.'s devices?
Among its 1 most recently registered device, Amcg Co., Ltd. has devices listed in FDA 510(k) (1 device).
What risk classes do Amcg Co., Ltd.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Amcg Co., Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Amcg Co., Ltd. in the registry?
The most recently registered devices listed for Amcg Co., Ltd. include MCG-S (AM1000).