Natus VikingQuest

FDA 510(k) K172743 · Natus Neurology Incorporated

Substantially Equivalent

510(k) numberK172743

Submission

Device name
Natus VikingQuest
Applicant
Natus Neurology Incorporated
Middleton, WI, US
Received
September 12, 2017
Decision date
December 19, 2017
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
IKN – Electromyograph, Diagnostic
Device class
Class II (moderate risk)
Regulation
21 CFR 890.1375
Specialty
Physical Medicine

Other 510(k)s with product code IKN

510(k)DeviceApplicantDecision
K163150ViMove2IKN · Special Dorsavi, Ltd.07/14/2017SE
K162383Cadwell Sierra Summit, Cadwell Sierra AscentIKN · Traditional Cadwell Industries, Inc.03/01/2017SE
K142494ViMoveIKN · Traditional Dorsavi, Ltd.05/28/2015SE
K131094VimoveIKN · Traditional Dorsa VI Pty., Ltd.07/11/2014SE
K123902Physical Monitoring Registration Unit-S (Pmru-S)IKN · Traditional Oktx, LLC09/13/2013SE
K123399Myovision 3.0 Wirefree SystemIKN · Traditional Precision Biometrics, Inc.08/01/2013SE
K113074Cmap ProIKN · Traditional Medical Technologies, Inc.02/02/2012SE
K102610Focus Emg DeviceIKN · Traditional Teleemg, LLC USA03/04/2011SE
K110048Cersr Electromyography SystemIKN · Special Spinematrix, Inc.01/26/2011SE
K083679Uroval BRS System, Model BRS01; Telesis, Model PROMO1IKN · Traditional Uroval09/11/2009SE

More from Uroval

510(k)DeviceDecision
K243982Nicolet EDXGWF · Special 01/22/2025SE
K243495Natus Ultrapro S100 (982A0594)GWF · Special 12/12/2024SE
K173366NicoletOneOLZ · Traditional 07/20/2018SE
K130346Synergy Focus Desktop Version; Synergy Focus Laptop VersionGWF · Special 05/02/2013SE

Questions and answers

When was Natus VikingQuest cleared by the FDA?

Natus VikingQuest (K172743) received a 510(k) decision of Substantially Equivalent on December 19, 2017, 98 days after the submission was received.

What is the product code of K172743?

The FDA product code is IKN – Electromyograph, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 890.1375.