Mitsar Co., Ltd.
RU Last updated 22 Oct 2026
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- Devices
- 1
- Registries
- FDA 510(k)
- FDA recalls
- 0
Catalogue
Mitsar-EEG Ref K143233
What Mitsar Co., Ltd. makes
Mitsar Co., Ltd. manufactures the Mitsar-EEG, a device designed for electroencephalography (EEG) to record electrical activity in the brain for diagnostic purposes.
The Mitsar-EEG is classified as a Class II medical device and is listed under the FDA’s 510(k) pathway. The company is based in the United States.
Frequently asked questions
What types of medical devices does Mitsar Co., Ltd. manufacture?
Mitsar Co., Ltd. specializes in the Mitsar-EEG, a device used for electroencephalography (EEG). This device records electrical activity in the brain, which is essential for diagnosing neurological conditions. The company focuses on diagnostic tools within this specific category.
Where is Mitsar Co., Ltd. based?
Mitsar Co., Ltd. is headquartered in the United States. The company’s location in the US may influence its regulatory compliance and market reach, particularly in regions where US-based manufacturers are recognized.
How are Mitsar Co., Ltd.’s devices classified under medical device regulations?
The Mitsar-EEG is classified as a Class II medical device. This classification typically means it poses moderate risks and requires special controls to ensure its safety and effectiveness, beyond general controls. Class II devices often require premarket notification (510(k)) submissions to regulatory bodies like the FDA.
Which regulatory registries or databases list Mitsar Co., Ltd.’s devices?
The Mitsar-EEG is listed under the FDA’s 510(k) pathway, indicating it has undergone the premarket notification process. This means the device is documented in the FDA’s 510(k) database, which serves as a registry for Class II devices that have been reviewed and deemed substantially equivalent to a predicate device.
Information
- Country
- RU