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FDA 510(k)

IKOENGELO, VERSION 2

K-Number: K083591 · 2008-12-29

ApplicantIkoetech, LLC
Decision Date2008-12-29
Product CodeKPQ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

IKOENGELO, VERSION 2 is the device name listed in this FDA 510(k) record. The listed applicant is Ikoetech, LLC. It received FDA 510(k) clearance on 2008-12-29 under 510(k) number K083591. The device is classified under product code KPQ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IKOENGELO, VERSION 2?

IKOENGELO, VERSION 2 is a medical device that received FDA 510(k) clearance on 2008-12-29. The listed applicant is Ikoetech, LLC. The 510(k) number is K083591.

When did IKOENGELO, VERSION 2 receive FDA 510(k) clearance?

IKOENGELO, VERSION 2 received FDA 510(k) clearance on 2008-12-29, under 510(k) number K083591.

Who is the listed applicant for IKOENGELO, VERSION 2?

The FDA 510(k) record lists Ikoetech, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IKOENGELO, VERSION 2?

The FDA product code for IKOENGELO, VERSION 2 is KPQ.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Ikoetech, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K061006IKOENGELO

Related Devices (Code: KPQ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K132045ADVANTAGESIM MD WITH CT ATLAS-BASED CONTOURING AND RE-PLANNING OPTIONSGe Hungary KftK101038RAD II SIMULATOR, RAD II KV IMAGER, DUAL RAD II KV IMAGERAcceletronics Digital Imaging, LLCK090706ONCENTRA SIMULATION 2.3Nucletron CorporationK072445INTEGRATED BRACHYTHERAPY UNIT - DIGITALNucletron Corp.K061006IKOENGELOIkoetech, LLCK052361SIMULIX-EVOLUTION WITH ONCENTRA CONEBEAMNucletron Corporation

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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