OEE_7102 EEG/TREND MONITOR— 510(k) K854662

Name: FDA 510(k) clearance K854662
Creator: U.S. Food and Drug Administration
Published: 1986-08-20

Substantially Equivalent

Nihon Kohden America, Inc.

FDA 510(k) clearance K854662 for OEE_7102 EEG/TREND MONITOR, Substantially Equivalent on 1986-08-20. Applicant: Nihon Kohden America, Inc.. Device class: 1.

Clearance details

Applicant: Nihon Kohden America, Inc.
Product code: Code GWS
Device class: Class 1
Regulation: 21 CFR 882.1420
Advisory panel: Neurology
Date received: 1985-11-20
Decision date: 1986-08-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

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