MODAC-XXXX Intensive Monitoring of EEG

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K860128 ↗

FDA Product Code

GYE

Device Class

Class II

Regulation

21 CFR Part 882.1855

Advisory Committee

Neurology

FDA Decision

SESE Substantially Equivalent

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  FDA 510(k) K870450 Active Cleared 8 Apr 1987

See all devices from Grass-Telefactor Product Group →

• What is the MODAC-XXXX Intensive Monitoring of EEG used for?

  The MODAC-XXXX is designed for continuous electroencephalogram (EEG) monitoring in intensive care settings, such as ICUs or neurocritical care units. It records brain wave activity over extended periods to help detect and analyze neurological conditions like seizures or abnormal patterns in critically ill patients. This allows clinicians to remotely or on-site monitor brain function, ensuring timely intervention for unstable neurological states.

• Is the MODAC-XXXX a single-use or reusable device?

  The MODAC-XXXX is a reusable medical device. It is intended for repeated use in clinical environments where continuous EEG monitoring is required. Reusability is supported by standard clinical disinfection protocols to maintain device reliability and patient safety between uses.

• What sterility or cleaning requirements apply to the MODAC-XXXX?

  The MODAC-XXXX does not have specified sterility requirements beyond standard clinical disinfection protocols. After each use, the device must be cleaned and maintained according to the manufacturer’s guidelines to ensure proper functionality and data integrity. These protocols are designed to prevent cross-contamination and preserve the device’s performance for ongoing patient monitoring.

• How is the MODAC-XXXX system supplied and where is it typically used?

  The MODAC-XXXX is supplied as a reusable system intended for clinical settings where continuous EEG monitoring is essential. It is primarily used in intensive care units (ICUs) or neurocritical care environments to provide real-time brainwave data acquisition and transmission. The system’s design supports long-term patient observation, making it suitable for high-dependency areas where neurological stability is critical.

• What regulatory approval does the MODAC-XXXX hold, and how was it reviewed?

  The MODAC-XXXX holds FDA 510(k) clearance under the reference number K860128. It was reviewed by the Neurology (NE) Advisory Committee in 1986 and classified as substantially equivalent to a predicate device under Regulation 882.1855. This classification reflects its role in specialized neurological assessments, ensuring it meets established safety and performance standards for EEG telemetry systems.