Danmeter A/S

Danmeter A/S manufactures the ELPHA series of devices, including models II 500, II 1000, II 2000, II 3000, and E80, as well as the ELPHA 4 CONTI. They also produce the Cerebral State Monitor (CSM) and the Automove, model AM800. These are the specific devices listed in the provided data, and no other products or markets are mentioned or implied.

Danmeter A/S is based in the United States, as explicitly stated in the SUMMARY section of the device data. The company’s country of origin is listed as US, and this is the only location information provided; no further details about facilities, headquarters, or regional operations are included.

Danmeter A/S's devices are listed in the FDA 510(k) registry, as stated in both the DEVICE CLASSES and LISTED IN fields and reiterated in the SUMMARY. This registry is used for premarket notification of medical devices in the United States, and the listing indicates that these devices have undergone the 510(k) submission process, though individual device authorizations are not confirmed or implied for the company as a whole.

Danmeter A/S's devices are classified as Class II medical devices, as specified in the DEVICE CLASSES field and confirmed in the SUMMARY. Class II devices are subject to special controls to ensure safety and effectiveness, such as performance standards, post-market surveillance, and specific labeling requirements, but this classification does not imply company-wide approval or certification—only that each listed device falls under this risk-based category.