XLTEK EMU40 EEG HEADBOX, MODEL PK1072— 510(k) K053386

Name: FDA 510(k) clearance K053386
Creator: U.S. Food and Drug Administration
Published: 2006-04-21

Substantially Equivalent

Excel Tech. , Ltd.

FDA 510(k) clearance K053386 for XLTEK EMU40 EEG HEADBOX, MODEL PK1072, Substantially Equivalent on 2006-04-21. Applicant: Excel Tech. , Ltd.. Device class: 2.

Clearance details

Applicant: Excel Tech. , Ltd.
Product code: Code GWQ
Device class: Class 2
Regulation: 21 CFR 882.1400
Advisory panel: Neurology
Date received: 2005-12-05
Decision date: 2006-04-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oakville, CA

Download summary PDF View on FDA.gov ↗

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