# K052066: Ceegraph/Sleepscan Netlink Traveler

- Pathway: 510(k) (Special)
- Applicant: Bio-Logic Systems Corp.
- Decided: Aug 26, 2005 after 25 days
- Product code: OLV (Standard Polysomnograph With Electroencephalograph)
- Device class: 2
- Regulation: 21 CFR 882.1400
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K930790 (1994). 5 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002570: Bio-Logic Ceegraph Netlink, Bio-Logic Systems Corp. (2000) Summary page 1.
- K003681: Bio-Logic Sleepscan Netlink, Bio-Logic Systems Corp. (2000) Summary page 1.
- K954954: Ceegraph Traveler Ambulatory Eeg Recorder, Bio-Logic Systems Corp. (1996) Summary page 1.
- K962103: Bio-Logic Sleepscan Product with Built-in Oximeter, Bio-Logic Systems Corp. (1996) Summary page 1.

## Most influential descendants
- K093728: BE Micro, Trea (2010), 4 descendants of its own
- K133355: Cadwell Flex Eeg/PSG (2014), 3 descendants of its own
- K180269: Cadwell Apollo System (2018), 2 descendants of its own
- K201819: Cadwell Apollo System (2020), 1 descendant of its own
- K221959: Q21 (2023), 0 descendants of its own

## Recalls of this device
- Jul 26, 2007 · Not classified · Z-0001-2008: Bio-logic System Corp Camera Pole may weaken and detach at the base of the telescoping camera pole during transport causing pole to break at the welded base and fall.
- Feb 26, 2007 · Not classified · Z-0761-2007: Battery and Battery Compartment; incorrect placement in the Netlink Traveler unit which caused a short in the wiring of the battery pack and overheating.

## Indications for use
The Bio-logic Ceegraph/Sleepscan Netlink Traveler is indicated for use in the recording and analysis of EEG tests. Typical routine EEG tests are 20-30 minutes in duration, but the Ceegraph/Sleepscan Netlink Traveler can also be used for longer tests, including continuous long-term EEG monitoring with patient video. Similarly, the Bio-logic Ceegraph/Sleepscan Netlink Traveler is indicated for use in the recording and analysis of human physiological data necessary for the diagnosis of Sleep-related disorders. It is intended to record and present this data in a form that can improve the speed of diagnosis and assist in potential treatment decisions. In general, EEG and Sleep testing is indicated for use whenever it is necessary to measure and record a patient's electrophysiological activity, including the electrical activity of the brain, by attaching multiple electrodes at various locations on the body. The Netlink Traveler can be used for patients of all ages, from children to adults, including geriatric patients. The use of the Ceegraph/Sleepscan Netlink Traveler is to be performed under the prescription and supervision of a physician or other trained health care professional.

Source page: https://510kreport.com/device/K052066
Methodology: https://510kreport.com/methodology