NEUROMETRIX BIOAMPLIFIER— 510(k) K083322

Substantially Equivalent

Neurometrix, Inc.

FDA 510(k) clearance K083322 for NEUROMETRIX BIOAMPLIFIER, Substantially Equivalent on 2009-05-27. Applicant: Neurometrix, Inc.. Device class: 2.

Clearance details

Applicant: Neurometrix, Inc.
Product code: Code GWL
Device class: Class 2
Regulation: 21 CFR 882.1835
Advisory panel: Neurology
Date received: 2008-11-12
Decision date: 2009-05-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waltham, MA, US

Download summary PDF View on FDA.gov ↗

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