FDA 510(k), K173571, Element System with IBT Electrodes

510(K) Number: K173571
Device Name: Element System with IBT Electrodes
Manufacturer: Infinite Biomedical Technologies, LLC
Device Classification Name: electrode, cutaneous
Regulation Number: 882.1320
Classification Product Code: GXY
Date Received: 11/20/2017
Decision Date: 03/21/2018
Regulation Medical Specialty: Neurology

Total pages: 2270
Fully redacted pages: 2118
Content pages: 152