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FDA 510(k)

Pollogen Legend System

K-Number: K173503 · 2018-06-11

ApplicantPollogen, Ltd.
Decision Date2018-06-11
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Pollogen Legend System is the device name listed in this FDA 510(k) record. The listed applicant is Pollogen, Ltd.. It received FDA 510(k) clearance on 2018-06-11 under 510(k) 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. The listed applicant is Pollogen, Ltd.. The 510(k) number is K173503.

When did Pollogen Legend System receive FDA 510(k) clearance?

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

Who is the listed applicant for Pollogen Legend System?

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

What is the FDA product code for Pollogen Legend System?

The FDA product code for Pollogen Legend System is GEI.

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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.

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