Cleared Special

Natus VikingQuest

K172743 · Natus Neurology Incorporated · Neurology
Dec 2017
Decision
98d
Days
Class 2
Risk

About This 510(k) Submission

K172743 is an FDA 510(k) clearance for the Natus VikingQuest, a Electromyograph, Diagnostic (Class II — Special Controls, product code IKN), submitted by Natus Neurology Incorporated (Middleton, US). The FDA issued a Cleared decision on December 19, 2017, 98 days after receiving the submission on September 12, 2017. This device falls under the Neurology review panel. Regulated under 21 CFR 890.1375.

Submission Details

510(k) Number K172743 FDA.gov
FDA Decision Cleared SESE
Date Received September 12, 2017
Decision Date December 19, 2017
Days to Decision 98 days
Submission Type Special
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code IKN — Electromyograph, Diagnostic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 890.1375