FDA 510(k)

ME-APDS; MAGENTIQ-COLO

K-Number: K223473 · 2023-07-25

Decision Date2023-07-25

Product CodeQNP

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

ME-APDS; MAGENTIQ-COLO is a medical device manufactured by Magentiq Eye, Ltd.. It received FDA 510(k) clearance on 2023-07-25 under approval number K223473. The device is classified under product code QNP. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ME-APDS; MAGENTIQ-COLO?

ME-APDS; MAGENTIQ-COLO is a medical device that received FDA 510(k) clearance on 2023-07-25. It is manufactured by Magentiq Eye, Ltd.. The 510(k) number is K223473.

When was ME-APDS; MAGENTIQ-COLO approved by the FDA?

ME-APDS; MAGENTIQ-COLO received FDA 510(k) clearance on 2023-07-25, under approval number K223473.

What company makes ME-APDS; MAGENTIQ-COLO?

ME-APDS; MAGENTIQ-COLO is manufactured by Magentiq Eye, Ltd..

What is the FDA product code for ME-APDS; MAGENTIQ-COLO?

The FDA product code for ME-APDS; MAGENTIQ-COLO is QNP.

Other Devices by Magentiq Eye, Ltd.

K252178MAGENTIQ-COLO (ME-APDS) K244023MAGENTIQ-COLO (ME-APDS) K260724MAGENTIQ-COLO (ME-APDS)

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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.