Question 1

What types of medical devices does Moberg Research, Inc. manufacture?

Accepted Answer

Moberg Research, Inc. specializes in multi-purpose digital medical cameras, electroencephalographic (EEG) monitoring systems, and EEG signal amplifiers. They also develop bioelectrical signal analysis software, which is used for clinical and research applications in neuromonitoring. These devices are designed to capture, amplify, and analyze electrical activity in the brain and other bioelectrical signals.

Question 2

Where is Moberg Research, Inc. based?

Accepted Answer

Moberg Research, Inc. is headquartered in the United States. The company’s location is relevant for understanding its regulatory framework and compliance with U.S. medical device standards.

Question 3

Which regulatory registries or databases list Moberg Research, Inc.’s devices?

Accepted Answer

Moberg Research, Inc.’s devices are included in the FDA’s 510(k) premarket notification database and the Unique Device Identifier (UDI) system. These registries help track and identify medical devices that have undergone the necessary regulatory processes for market authorization in the U.S.

Question 4

How are Moberg Research, Inc.’s devices classified under FDA regulations?

Accepted Answer

Moberg Research, Inc.’s devices fall under Class II classification according to FDA regulations. This classification typically applies to devices that pose moderate risk and require special controls in addition to general controls to ensure their safety and effectiveness. The specific controls for these devices are outlined in FDA guidance and regulations.

Question 5

Are Moberg Research, Inc.’s devices used for both clinical and research purposes?

Accepted Answer

Yes, Moberg Research, Inc.’s devices, including their EEG monitoring systems, amplifiers, and bioelectrical signal analysis software, are designed for both clinical and research applications. Their multi-purpose digital cameras and neuromonitoring systems are particularly useful in settings like operating rooms, intensive care units, and research labs where continuous monitoring of brain activity is critical.

Device	Model / Reference	Registries	Class	Status
Component Neuromonitoring System	CNS-320	FDA UDI	Class II	Active
Component Monitoring System	CNS-PTZ-350	FDA UDI	Class II	Active
Component Neuromonitoring System	CNS-INX-300	FDA UDI	Class II	Active
Component Neuromonitoring System	CNS-EEG-300	FDA UDI	Class II	Active
Component Monitoring System	CNS-VID-370	FDA UDI	Class II	Active
Component Neuromonitoring System	CNS-350	FDA UDI	Class II	Active
Component Neuromonitoring System	CNS-EEG-220	FDA UDI	Class II	Active
Component Neuromonitoring System	CNS-EEG-310	FDA UDI	Class II	Active
Component Neuromonitoring System	CNS-EEG-320	FDA UDI	Class II	Active
CNS Envision	VIS-100	FDA UDI	Class II	Active
Component Neuromonitoring System	CNS-INX-310	FDA UDI	Class II	Active
Component Neuromonitoring System	CNS-VID-320	FDA UDI	Class II	Active
Component Neuromonitoring System	CNS-INX-320	FDA UDI	Class II	Active
Component Neuromonitoring System	CNS-310	FDA UDI	Class II	Active
Component Neuromonitoring System	CNS-300	FDA UDI	Class II	Active
Component Monitoring System	CNS-VID-350	FDA UDI	Class II	Active
Component Neuromonitoring System	CNS-EEG-200	FDA UDI	Class II	Active
Component Neuromonitoring System	CNS-VID-300	FDA UDI	Class II	Active
Component Neuromonitoring System	CNS-PTZ-310	FDA UDI	Class II	Active
Component Neuromonitoring System	CNS-PTZ-300	FDA UDI	Class II	Active
Component Neuromonitoring System	CNS-VID-310	FDA UDI	Class II	Active
Component Neuromonitoring System	CNS-EEG-210	FDA UDI	Class II	Active
Component Neuromonitoring System	K080217	FDA 510(k)	Class II	Active
CNS Envision	K192572	FDA 510(k)	Class II	Active

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