Cleared Traditional

MAGNES 2500 WH BIOMAGNETOMETER

K962317 · Biomagnetic Technologies, Inc. · Neurology
May 1997
Decision
324d
Days
Class 2
Risk

About This 510(k) Submission

K962317 is an FDA 510(k) clearance for the MAGNES 2500 WH BIOMAGNETOMETER, a Magnetoencephalograph (Class II — Special Controls, product code OLY), submitted by Biomagnetic Technologies, Inc. (San Diego, US). The FDA issued a Cleared decision on May 7, 1997, 324 days after receiving the submission on June 17, 1996. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1400.

Submission Details

510(k) Number K962317 FDA.gov
FDA Decision Cleared SESE
Date Received June 17, 1996
Decision Date May 07, 1997
Days to Decision 324 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code OLY — Magnetoencephalograph
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.1400
Definition Acquire, Display, Store, And Archive Biomagnetic Signals Produced By Electrically Active Nerve Tissue In The Brain To Provide Information About The Location Of Active Nerve Tissue Responsible For Certain Brain Functions Relative To Brain Anatomy.