Neurolink Ip, Model PK1113

FDA 510(k) K081741 · Excel-Tech Ltd. (Xltek)

Substantially Equivalent

510(k) numberK081741

Submission

Device name
Neurolink Ip, Model PK1113
Applicant
Excel-Tech Ltd. (Xltek)
Oakville, CA
Received
June 19, 2008
Decision date
October 31, 2008
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
GWQ – Full-Montage Standard Electroencephalograph
Device class
Class II (moderate risk)
Regulation
21 CFR 882.1400
Specialty
Neurology

Acquire, display, store, and archive electroencephalographic signals from the brain using a full montage array (i.e., 16 or more electrodes) and user-specified locations

Other 510(k)s with product code GWQ

510(k)DeviceApplicantDecision
K261604Enobio Dx (Enobio Dx 8);Enobio Dx (Enobio Dx 20);Enobio Dx (Enobio Dx 32)GWQ · Special Neuroelectrics Barcelona S.L.U.06/13/2026SE
K260455New Wave SystemGWQ · Special Zeto, Inc.03/13/2026SE
K233403Flexset SystemGWQ · Traditional Zeto, Inc.04/30/2024SE
K231366Neuronaute PlusGWQ · Traditional Bioserenity Sas11/09/2023SE
K221959Q21GWQ · Traditional Neurofield, Inc.08/31/2023SE
K231457SPARK ScanGWQ · Traditional Spark Neuro, Inc.08/18/2023SE
K221963Cumulus Functional Neurophysiology PlatformGWQ · Traditional Cumulus Neuroscience Limited04/27/2023SE
K230073OktiGWQ · Traditional Compumedics Limited02/09/2023SE
K223644Neuronaute with IceCap 2 & IceCap 2 SmallGWQ · Special Bioserenity01/12/2023SE
K220056iSyncWaveGWQ · Traditional iMediSync, Inc.08/10/2022SE

More from iMediSync, Inc.

510(k)DeviceDecision
K131266Trez_HdGWQ · Traditional 02/14/2014SE
K123079Olympic Brainz MonitorOMA · Traditional 05/08/2013SE
K120260IctaOMB · Traditional 06/29/2012SE
K090277Natus Sleepworks, Model 104017OLZ · Traditional 04/19/2011SE
K100126Stellate GridviewOLX · Abbreviated 12/03/2010SE

Questions and answers

When was Neurolink Ip, Model PK1113 cleared by the FDA?

Neurolink Ip, Model PK1113 (K081741) received a 510(k) decision of Substantially Equivalent on October 31, 2008, 134 days after the submission was received.

What is the product code of K081741?

The FDA product code is GWQ – Full-Montage Standard Electroencephalograph, a Class II (moderate risk) device regulated under 21 CFR 882.1400.