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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 the device name listed in this FDA 510(k) record. The listed applicant is Philips Medical Systems Nederland B.V.. It received FDA 510(k) clearance on 2018-03-06 under 510(k) 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. The listed applicant is Philips Medical Systems Nederland B.V.. The 510(k) number is K173356.

When did Ingenia Elition S and Ingenia Elition X R5.4 receive FDA 510(k) clearance?

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

Who is the listed applicant for Ingenia Elition S and Ingenia Elition X R5.4?

The FDA 510(k) record lists Philips Medical Systems Nederland B.V. as the applicant. This does not by itself establish the device manufacturer.

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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