Dual Chennel Brain Activity Monitor

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K843808 ↗

FDA Product Code

OLT

Device Class

Class II

Regulation

21 CFR Part 882.1400

Advisory Committee

Neurology

FDA Decision

SESE Substantially Equivalent

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• What clinical settings is the Dual Channel Brain Activity Monitor designed for, and how does it help in those environments?

  The Dual Channel Brain Activity Monitor is specifically designed for use in clinical settings like intensive care units (ICUs) and operating rooms where continuous neurological monitoring is critical. It records brain activity through dual-channel electroencephalography (EEG) to assess neurological function, helping clinicians evaluate conditions such as seizures, coma, or other neurological disorders in real-time.

• Is the Dual Channel Brain Activity Monitor intended for single-use or reusable applications, and what does this mean for maintenance?

  The Dual Channel Brain Activity Monitor is classified as a reusable device under 21 CFR 882.1400, meaning it is not designed for single-use. This implies that it requires proper cleaning, disinfection, and maintenance between uses to ensure reliability and safety in clinical environments.

• What regulatory pathway was followed for FDA clearance of this device, and what does this indicate about its safety and effectiveness?

  The Dual Channel Brain Activity Monitor received FDA 510(k) clearance (K843808) through a traditional review process, with a decision described as 'Substantially Equivalent' to a predicate device. This indicates that the FDA determined the device met the same safety and performance criteria as an existing, legally marketed device, ensuring it meets regulatory standards for use in clinical settings.

• Are there multiple models or variations of this device, and how can I identify the correct one for my needs?

  Yes, the Dual Channel Brain Activity Monitor appears to have multiple registration numbers and FEI numbers listed, which may correspond to different models or variations. These identifiers (e.g., 3004762958, 3011184129) are used for regulatory tracking and may help in identifying the specific model or configuration required for your clinical or operational needs. Always verify the exact model with the manufacturer or distributor.