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

Name: FDA 510(k) clearance K092477
Creator: U.S. Food and Drug Administration
Published: 2010-10-29

Substantially Equivalent

Neurowave Systems, Inc.

FDA 510(k) clearance K092477 for NeuroWave NeuroFAST MONITORING SYSTEM, MODEL NF-701, Substantially Equivalent on 2010-10-29. Applicant: Neurowave Systems, Inc.. Device class: 2.

Clearance details

Applicant: Neurowave Systems, Inc.
Product code: Code OMC
Device class: Class 2
Regulation: 21 CFR 882.1400
Advisory panel: Neurology
Date received: 2009-08-12
Decision date: 2010-10-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cleveland Heights, OH, US

Download summary PDF View on FDA.gov ↗

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