Cleared Special

BIOMAGNETIC TECHNOLOGIES MAGNES 3600 WHOLE HEAD MEG

K993708 · Biomagnetic Technologies, Inc. · Neurology

Dec 1999

Decision

30d

Days

Class 2

Risk

About This 510(k) Submission

K993708 is an FDA 510(k) clearance for the BIOMAGNETIC TECHNOLOGIES MAGNES 3600 WHOLE HEAD MEG, 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 December 3, 1999, 30 days after receiving the submission on November 3, 1999. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1400.

Submission Details

510(k) Number	K993708 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 03, 1999
Decision Date	December 03, 1999
Days to Decision	30 days
Submission Type	Special
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