Cleared Traditional

NEUROMAG-122

K962764 · Philips Medical Systems (Cleveland), Inc. · Neurology

Oct 1996

Decision

107d

Days

Class 2

Risk

About This 510(k) Submission

K962764 is an FDA 510(k) clearance for the NEUROMAG-122, a Magnetoencephalograph (Class II — Special Controls, product code OLY), submitted by Philips Medical Systems (Cleveland), Inc. (Highland Heights, US). The FDA issued a Cleared decision on October 31, 1996, 107 days after receiving the submission on July 16, 1996. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1400.

Submission Details

510(k) Number	K962764 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 16, 1996
Decision Date	October 31, 1996
Days to Decision	107 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.