ESG-1 (EVOKED RESPONSE STIMULUS GENER)— 510(k) K801671

Name: FDA 510(k) clearance K801671
Creator: U.S. Food and Drug Administration
Published: 1980-08-04

Substantially Equivalent

Neurodiagnostics, Inc.

FDA 510(k) clearance K801671 for ESG-1 (EVOKED RESPONSE STIMULUS GENER), Substantially Equivalent on 1980-08-04. Applicant: Neurodiagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Neurodiagnostics, Inc.
Product code: Code GWE
Device class: Class 2
Regulation: 21 CFR 882.1890
Advisory panel: Neurology
Date received: 1980-07-22
Decision date: 1980-08-04
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.