Aitrics Co., Ltd.
South KoreaFDA applicant, unverified
- Devices
- 1
What Aitrics Co., Ltd. makes
Aitrics Co., Ltd. manufactures the AITRICS-VC, a medical device designed for ventricular contractility assessment, likely used in cardiac monitoring or diagnostic settings to evaluate heart function.
The company’s portfolio is regulated under Class II devices in the United States, with the AITRICS-VC authorised via the FDA’s 510(k) pathway. The manufacturer is based in the US.
Catalogue
Aitrics-Vc Ref K240756
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Aitrics Co., Ltd. have in the registry?
The registry currently lists 1 device for Aitrics Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Aitrics Co., Ltd.'s devices?
Among its 1 most recently registered device, Aitrics Co., Ltd. has devices listed in FDA 510(k) (1 device).
What risk classes do Aitrics Co., Ltd.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Aitrics Co., Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Aitrics Co., Ltd. in the registry?
The most recently registered devices listed for Aitrics Co., Ltd. include AITRICS-VC.