NeuroSENSE NS-901

Trade name

NeuroSENSE

Generic name

Anaesthesia depth monitor

Model / reference

NS-901

Primary DI / UDI-DI

B746NS90101

FDA product code

OLW

GMDN term

Anaesthesia depth monitor

Device class

Class II

Regulation number

882.1400

GUDID distribution status

In Commercial Distribution

MRI safety

MR Unsafe

Category: Anaesthesia depth monitor

Other devices filed under FDA product code OLW (Index-Generating Electroencephalograph Software).

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• PSA4000 EEG MONITOR WITH FRONTAL PSI by Physiometrix, Inc.
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• A-1000 EEG MONITOR AND A-1050 EEG MONITOR by Aspect Medical Systems, Inc.

• NeuroSENSE Monitoring System, Model NS-901

  Class II

  FDA 510(k) K202621 Active Cleared 5 Aug 2021

• DiscoverEEG System, Model DE-401

  Class II

  FDA 510(k) K142834 Active Cleared 23 Jun 2015

• NeuroWave NeuroFAST MONITORING SYSTEM, MODEL NF-701

  Class II

  FDA 510(k) K092477 Active Cleared 29 Oct 2010

• EasyPrep electrodes

  Class I

  CE/MDR GUDID on market