NEUROWAVE SYSTEM 2— 510(k) K883557

Substantially Equivalent

Durden Enterprises, Inc.

FDA 510(k) clearance K883557 for NEUROWAVE SYSTEM 2, Substantially Equivalent on 1988-12-16. Applicant: Durden Enterprises, Inc.. Device class: 2.

Clearance details

Applicant: Durden Enterprises, Inc.
Product code: Code GWQ
Device class: Class 2
Regulation: 21 CFR 882.1400
Advisory panel: Neurology
Date received: 1988-08-19
Decision date: 1988-12-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Auburn, GA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.