FDA 510(k)

Pollogen Legend System

K-Number: K173503 · 2018-06-11

Decision Date2018-06-11

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

Pollogen Legend System is a medical device manufactured by Pollogen, Ltd.. It received FDA 510(k) clearance on 2018-06-11 under approval number K173503. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Pollogen Legend System?

Pollogen Legend System is a medical device that received FDA 510(k) clearance on 2018-06-11. It is manufactured by Pollogen, Ltd.. The 510(k) number is K173503.

When was Pollogen Legend System approved by the FDA?

Pollogen Legend System received FDA 510(k) clearance on 2018-06-11, under approval number K173503.

What company makes Pollogen Legend System?

Pollogen Legend System is manufactured by Pollogen, Ltd..

What is the FDA product code for Pollogen Legend System?

The FDA product code for Pollogen Legend System is GEI.

Other Devices by Pollogen, Ltd.

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Official Source

View on FDA Database →

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