# K131415: Live View Panel (LVP)

- Pathway: 510(k) (Traditional)
- Applicant: Neurotronics, Inc.
- Decided: Aug 9, 2013 after 85 days
- Product code: OLV (Standard Polysomnograph With Electroencephalograph)
- Device class: 2
- Regulation: 21 CFR 882.1400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K915494 (1993). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080546: Nihon Kohden Eeg-1200A Series Neurofax, Model Eeg-1200A, Nihon Kohden America, Inc. (2008) Summary page 2.
- K062943: Polysmith Sleep System, Model NTI5498, Neurotronics, Inc. (2007) Summary page 2.
- K120888: PSG-1100 Sleep Diagnostic System, Nihon Kohden Corp. (2012) Summary page 2.
- K113117: Nihon Kohden Eeg-1200A with JE-120A Multi Channel Electrode Junction Box, Nihon Kohden America, Inc. (2012) Summary page 2.

## Indications for use
The Live View Panel is an accessory to EEG and PSG systems, intended to transmit EEG or PSG data to a remote location where the data can be viewed by a clinician to aid in diagnosis of epilepsies, sleep disorders, and other related disorders The Live View Panel is intended for use by medical personnel within a medical facility, clinic or nursing home, or outside a medical facility under the supervision of a medical professional. The Live View Panel is available for use on all patient populations, including adults and children as determined by the medical professional. This device is not to be used to monitor life threatening situations. This device is not to be used to control life supporting or life sustaining devices.

Source page: https://510kreport.com/device/K131415
Methodology: https://510kreport.com/methodology