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FDA 510(k)

IMAGE WORKS PANOURA

K-Number: K122806 · 2013-03-08

ApplicantMic International
Decision Date2013-03-08
Product CodeMUH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

IMAGE WORKS PANOURA is the device name listed in this FDA 510(k) record. The listed applicant is Mic International. It received FDA 510(k) clearance on 2013-03-08 under 510(k) number K122806. The device is classified under product code MUH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMAGE WORKS PANOURA?

IMAGE WORKS PANOURA is a medical device that received FDA 510(k) clearance on 2013-03-08. The listed applicant is Mic International. The 510(k) number is K122806.

When did IMAGE WORKS PANOURA receive FDA 510(k) clearance?

IMAGE WORKS PANOURA received FDA 510(k) clearance on 2013-03-08, under 510(k) number K122806.

Who is the listed applicant for IMAGE WORKS PANOURA?

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

What is the FDA product code for IMAGE WORKS PANOURA?

The FDA product code for IMAGE WORKS PANOURA is MUH.

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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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