NEURO DIAGNOSTICS MODEL FCR— 510(k) K830191

Name: FDA 510(k) clearance K830191
Creator: U.S. Food and Drug Administration
Published: 1983-02-18

Substantially Equivalent

Neurodiagnostics, Inc.

FDA 510(k) clearance K830191 for NEURO DIAGNOSTICS MODEL FCR, Substantially Equivalent on 1983-02-18. Applicant: Neurodiagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Neurodiagnostics, Inc.
Product code: Code GWK
Device class: Class 2
Regulation: 21 CFR 882.1845
Advisory panel: Neurology
Date received: 1983-01-20
Decision date: 1983-02-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, 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.