# K120397: Meb-2300A Neuropack Evoked Potential and Emg Measuring System

- Pathway: 510(k) (Traditional)
- Applicant: Nihon Kohden Corp.
- Decided: Sep 19, 2012 after 224 days
- Product code: GWF (Stimulator, Electrical, Evoked Response)
- Device class: 2
- Regulation: 21 CFR 882.1870
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K950208 (1995). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991899: Nihon Kohden Meb-2200A Neuropack Evoked Potential & Emg Measuring System with Accessories, Nihon Kohden America, Inc. (1999) Summary page 1.

## Most influential descendants
- K191700: EyeStat (2019), 0 descendants of its own

## Indications for use
The Nihon Kohden MEB-2300A Neuropack Evoked Potential and EMG Measuring System is intended to monitor, record and display the bioelectric signals produced by muscles, to stimulate peripheral nerves, and to monitor, record and display the electrical activity produced by nerves to aid the clinician in the diagnosis and prognosis of neuromuscular disease (EMG). The device is also intended to measure and display nerve conduction time by applying a stimulus to a patient's nerve (NCV). The device may use electrical stimulus, visual stimulus, or sound stimulus for use in evoked response measurements (EP). The device may be used to determine autonomic responses as psychological indicators by measuring the electrical resistance of the skin and the tissue path between two electrodes applied to the skin. The device may also measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head (EEG). The device is intended for' use by medical personnel within a hospital, laboratory, clinic or nursing home setting or outside of a medical facility under direct supervision of a medical professional. The device may also be placed in the intensive care unit or operating room for continuous recording. The device is available for use on any patient as determined by the medical professional including adults and children.

Source page: https://510kreport.com/device/K120397
Methodology: https://510kreport.com/methodology