Cleared Traditional

Background Pattern Classification [BPc(TM)]

K152301 · Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) · Neurology

Jun 2016

Decision

294d

Days

Class 2

Risk

About This 510(k) Submission

K152301 is an FDA 510(k) clearance for the Background Pattern Classification [BPc(TM)], a Amplitude-integrated Electroencephalograph (Class II — Special Controls, product code OMA), submitted by Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) (Oakville, CA). The FDA issued a Cleared decision on June 3, 2016, 294 days after receiving the submission on August 14, 2015. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1400.

Submission Details

510(k) Number	K152301 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 14, 2015
Decision Date	June 03, 2016
Days to Decision	294 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF

Device Classification

Product Code	OMA — Amplitude-integrated Electroencephalograph
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 882.1400
Definition	Measure And Record Electrical Activity Of The Brain By Acquisition Of Amplitude-integrated Electroencephalograph (electroencephalograph Signals That Have Been Filtered And Displayed In A Specific Manner).