IKOENGELO, VERSION 2— 510(k) K083591

Substantially Equivalent

Ikoetech, LLC

FDA 510(k) clearance K083591 for IKOENGELO, VERSION 2, Substantially Equivalent on 2008-12-29. Applicant: Ikoetech, LLC. Device class: 2.

Clearance details

Applicant: Ikoetech, LLC
Product code: Code KPQ
Device class: Class 2
Regulation: 21 CFR 892.5840
Advisory panel: Radiology
Date received: 2008-12-04
Decision date: 2008-12-29
Decision: Substantially Equivalent
Clearance type: Special
Location: Houston, TX, US

Download summary PDF View on FDA.gov ↗

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