WIRELESS EEG RECORDING SYSTEM MODEL W32— 510(k) K963195

Name: FDA 510(k) clearance K963195
Creator: U.S. Food and Drug Administration
Published: 1997-07-29

Substantially Equivalent

Cme Telemetrix, Inc.

FDA 510(k) clearance K963195 for WIRELESS EEG RECORDING SYSTEM MODEL W32, Substantially Equivalent on 1997-07-29. Applicant: Cme Telemetrix, Inc.. Device class: 2.

Clearance details

Applicant: Cme Telemetrix, Inc.
Product code: Code GYE
Device class: Class 2
Regulation: 21 CFR 882.1855
Advisory panel: Neurology
Date received: 1996-08-15
Decision date: 1997-07-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Cadwell, NJ, US

Download summary PDF View on FDA.gov ↗

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