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FDA 510(k)

IGROK

K-Number: K080325 · 2008-04-08

ApplicantIgrok, LLC
Decision Date2008-04-08
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

IGROK is the device name listed in this FDA 510(k) record. The listed applicant is Igrok, LLC. It received FDA 510(k) clearance on 2008-04-08 under 510(k) number K080325. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IGROK?

IGROK is a medical device that received FDA 510(k) clearance on 2008-04-08. The listed applicant is Igrok, LLC. The 510(k) number is K080325.

When did IGROK receive FDA 510(k) clearance?

IGROK received FDA 510(k) clearance on 2008-04-08, under 510(k) number K080325.

Who is the listed applicant for IGROK?

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

What is the FDA product code for IGROK?

The FDA product code for IGROK is LLZ.

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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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