Cleared Traditional

BIS INTERFACE FOR VITALOGIK PATIENT MONITORS

K083063 · Mennen Medical , Ltd. · Neurology

Dec 2008

Decision

63d

Days

Class 2

Risk

About This 510(k) Submission

K083063 is an FDA 510(k) clearance for the BIS INTERFACE FOR VITALOGIK PATIENT MONITORS, a Index-generating Electroencephalograph Software (Class II — Special Controls, product code OLW), submitted by Mennen Medical , Ltd. (Rohovot, IL). The FDA issued a Cleared decision on December 16, 2008, 63 days after receiving the submission on October 14, 2008. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1400.

Submission Details

510(k) Number	K083063 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 14, 2008
Decision Date	December 16, 2008
Days to Decision	63 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF

Device Classification

Product Code	OLW — Index-generating Electroencephalograph Software
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 882.1400
Definition	Analyze Electrical Activity Of The Brain By Transformation Of Electroencephalograph Signals Into A Dimensionless Index Number For Use And Interpretation By A Qualified User.