Cleared Traditional

700 SERIES BIOMAGNETOMETER

K901215 · Biomagnetic Technologies, Inc. · Neurology

Jun 1990

Decision

103d

Days

Class 2

Risk

About This 510(k) Submission

K901215 is an FDA 510(k) clearance for the 700 SERIES 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 June 25, 1990, 103 days after receiving the submission on March 14, 1990. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1400.

Submission Details

510(k) Number	K901215 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 14, 1990
Decision Date	June 25, 1990
Days to Decision	103 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	—

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