Micro-Star International Co., Ltd.
TaiwanFDA applicant, unverified
- Devices
- 1
What Micro-Star International Co., Ltd. makes
Micro-Star International Co., Ltd. manufactures portable electrocardiogram (ECG) devices, including the E3-80 Portable ECG Recorder & Analyzer, designed for on-site cardiac monitoring and diagnostic analysis.
The company’s ECG devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. These products are intended for use in the United States.
Catalogue
E3-80 Portable Ecg Recorder & Analyzer Ref K071085
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Micro-Star International Co., Ltd. have in the registry?
The registry currently lists 1 device for Micro-Star International Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Micro-Star International Co., Ltd.'s devices?
Among its 1 most recently registered device, Micro-Star International Co., Ltd. has devices listed in FDA 510(k) (1 device).
What risk classes do Micro-Star International Co., Ltd.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Micro-Star International Co., Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Micro-Star International Co., Ltd. in the registry?
The most recently registered devices listed for Micro-Star International Co., Ltd. include E3-80 PORTABLE ECG RECORDER & ANALYZER.