510(k) K172743

Natus VikingQuest by Natus Neurology Incorporated — Product Code IKN

K172743 is an FDA 510(k) premarket notification submitted by Natus Neurology Incorporated for the device "Natus VikingQuest". The FDA issued a decision of Substantially Equivalent on December 19, 2017. The device falls under product code IKN (Electromyograph, Diagnostic), a Class II device regulated under 21 CFR 890.1375. Natus Neurology Incorporated has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 19, 2017
Date Received
September 12, 2017
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electromyograph, Diagnostic
Device Class
Class II
Regulation Number
890.1375
Review Panel
NE
Submission Type