EMU128S, MODEL EX-NW-128S— 510(k) K040360

Substantially Equivalent

Excel Tech. , Ltd.

FDA 510(k) clearance K040360 for EMU128S, MODEL EX-NW-128S, Substantially Equivalent on 2004-03-12. 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: 2004-02-13
Decision date: 2004-03-12
Decision: Substantially Equivalent
Clearance type: Special
Location: Oakville, Ontario, CA

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.