Cleared Traditional

K092477 - NeuroWave NeuroFAST MONITORING SYSTEM, MODEL NF-701
(FDA 510(k) Clearance)

K092477 · Neurowave Systems, Inc. · Neurology

Oct 2010

Decision

443d

Days

Class 2

Risk

K092477 is an FDA 510(k) clearance for the NeuroWave NeuroFAST MONITORING SYSTEM, MODEL NF-701, a Reduced- Montage Standard Electroencephalograph (Class II — Special Controls, product code OMC), submitted by Neurowave Systems, Inc. (Cleveland Heights, US). The FDA issued a Cleared decision on October 29, 2010, 443 days after receiving the submission on August 12, 2009. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1400.

Submission Details

510(k) Number	K092477 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 12, 2009
Decision Date	October 29, 2010
Days to Decision	443 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF

Device Classification

Product Code	OMC — Reduced- Montage Standard Electroencephalograph
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 882.1400
Definition	Acquire, Display, Store, And Archive Electroencephalographic Signals From The Brain Using A User-specified And/or Sponsor-specified Locations With A Reduced Array (i.e. Less Than < 16) Of Electrodes