Biomagnetic Technologies Neuromagneometer

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K854466 ↗

FDA product code

OLY

Device class

Class II

Regulation

21 CFR Part 882.1400

Advisory committee

Neurology

FDA decision

SESE Substantially Equivalent

• 700 Series Biomagnetometer

  Class II

  FDA 510(k) K901215 Active Cleared 25 Jun 1990

• Generator, Biotec 876 Pulse

  Not classified

  FDA 510(k) K790031 Active Cleared 2 Jan 1979

• Ibt Model Svi

  Class II

  FDA 510(k) K921821 Active Cleared 2 Nov 1992

• Magnes 2500 Wh Biomagnetometer

  Class II

  FDA 510(k) K962317 Active Cleared 7 May 1997

• Somatosensory Stimulus System

  Class II

  FDA 510(k) K913604 Active Cleared 9 Dec 1991

• Magnes II Biomagnetometer

  Class II

  FDA 510(k) K941553 Active Cleared 16 May 1996

See all devices from Biomagnetic Technologies, Inc. →

• What is the Biomagnetic Technologies Neuromagnetometer used for?

  The Neuromagnetometer is a magnetoencephalograph device that measures magnetic fields produced by neural activity in the brain, assisting in neurological assessment and research by detecting and recording magnetic signals associated with brain function.

• How is the Neuromagnetometer supplied and what is its regulatory classification?

  The device is supplied by Biomagnetic Technologies, Inc. and is classified as a Class II medical device with FDA 510(k) clearance K854466, intended for use in clinical and research settings within the field of neurology.

• Is the Neuromagnetometer single-use or reusable, and does it require special storage conditions?

  The device data does not specify whether the Neuromagnetometer is single-use or reusable, nor does it provide information regarding sterility requirements or special storage conditions.

• What sizes and models of the Neuromagnetometer are available?

  The device data does not specify different sizes or models of the Neuromagnetometer available, only that it is a magnetoencephalograph device manufactured by Biomagnetic Technologies, Inc.