Cleared Traditional

BABYMEG BIOMAGNETOMETER SYSTEM

K133419 · Tristan Technologies, Inc. · Neurology
Jul 2014
Decision
256d
Days
Class 2
Risk

About This 510(k) Submission

K133419 is an FDA 510(k) clearance for the BABYMEG BIOMAGNETOMETER SYSTEM, a Magnetoencephalograph (Class II — Special Controls, product code OLY), submitted by Tristan Technologies, Inc. (Encinitas, US). The FDA issued a Cleared decision on July 21, 2014, 256 days after receiving the submission on November 7, 2013. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1400.

Submission Details

510(k) Number K133419 FDA.gov
FDA Decision Cleared SESE
Date Received November 07, 2013
Decision Date July 21, 2014
Days to Decision 256 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.