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FDA 510(k)

Ingenia Elition S and Ingenia Elition X R5.4

K-Number: K173356 · 2018-03-06

ApplicantPhilips Medical Systems Nederland B.V.
Decision Date2018-03-06
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Ingenia Elition S and Ingenia Elition X R5.4 is a medical device manufactured by Philips Medical Systems Nederland B.V.. It received FDA 510(k) clearance on 2018-03-06 under approval number K173356. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Ingenia Elition S and Ingenia Elition X R5.4?

Ingenia Elition S and Ingenia Elition X R5.4 is a medical device that received FDA 510(k) clearance on 2018-03-06. It is manufactured by Philips Medical Systems Nederland B.V.. The 510(k) number is K173356.

When was Ingenia Elition S and Ingenia Elition X R5.4 approved by the FDA?

Ingenia Elition S and Ingenia Elition X R5.4 received FDA 510(k) clearance on 2018-03-06, under approval number K173356.

What company makes Ingenia Elition S and Ingenia Elition X R5.4?

Ingenia Elition S and Ingenia Elition X R5.4 is manufactured by Philips Medical Systems Nederland B.V..

What is the FDA product code for Ingenia Elition S and Ingenia Elition X R5.4?

The FDA product code for Ingenia Elition S and Ingenia Elition X R5.4 is LNH.

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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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