Cleared Traditional

BIOMAGNETIC TECHNOLOGIES NEUROMAGNEOMETER

K854466 · Biomagnetic Technologies, Inc. · Neurology
Feb 1986
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K854466 is an FDA 510(k) clearance for the BIOMAGNETIC TECHNOLOGIES NEUROMAGNEOMETER, a Magnetoencephalograph (Class II — Special Controls, product code OLY), submitted by Biomagnetic Technologies, Inc. (San Diego, US). The FDA issued a Cleared decision on February 4, 1986, 90 days after receiving the submission on November 6, 1985. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1400.

Submission Details

510(k) Number K854466 FDA.gov
FDA Decision Cleared SESE
Date Received November 06, 1985
Decision Date February 04, 1986
Days to Decision 90 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary —

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.