Cleared Traditional

MAGNES II BIOMAGNETOMETER

K941553 · Biomagnetic Technologies, Inc. · Neurology
May 1996
Decision
778d
Days
Class 2
Risk

About This 510(k) Submission

K941553 is an FDA 510(k) clearance for the MAGNES II BIOMAGNETOMETER, a Source Localization Software For Electroencephalograph Or Magnetoencephalograph (Class II — Special Controls, product code OLX), submitted by Biomagnetic Technologies, Inc. (San Diego, US). The FDA issued a Cleared decision on May 16, 1996, 778 days after receiving the submission on March 30, 1994. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1400.

Submission Details

510(k) Number K941553 FDA.gov
FDA Decision Cleared SESE
Date Received March 30, 1994
Decision Date May 16, 1996
Days to Decision 778 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code OLX — Source Localization Software For Electroencephalograph Or Magnetoencephalograph
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.1400
Definition Correlation Of Electrical Activity Of The Brain Using Various Neuroimaging Modalities For Source-localization