XLTEK CONNEX IP HEADBOX, MODEL 1054— 510(k) K042223

Name: FDA 510(k) clearance K042223
Creator: U.S. Food and Drug Administration
Published: 2004-09-16

Substantially Equivalent

Excel Tech. , Ltd.

FDA 510(k) clearance K042223 for XLTEK CONNEX IP HEADBOX, MODEL 1054, Substantially Equivalent on 2004-09-16. Applicant: Excel Tech. , Ltd.. Device class: 2.

Clearance details

Applicant: Excel Tech. , Ltd.
Product code: Code OMB
Device class: Class 2
Regulation: 21 CFR 882.1400
Advisory panel: Neurology
Date received: 2004-08-17
Decision date: 2004-09-16
Decision: Substantially Equivalent
Clearance type: Special
Location: Oakville, CA

Download summary PDF View on FDA.gov ↗

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