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FDA 510(k)

KODEX EPD System

K-Number: K180940 · 2018-10-24

ApplicantPhilips Medical Systems Nederland B.V.
Decision Date2018-10-24
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

KODEX EPD System 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 2018-10-24 under 510(k) number K180940. The device is classified under product code DQK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KODEX EPD System?

KODEX EPD System is a medical device that received FDA 510(k) clearance on 2018-10-24. The listed applicant is Philips Medical Systems Nederland B.V.. The 510(k) number is K180940.

When did KODEX EPD System receive FDA 510(k) clearance?

KODEX EPD System received FDA 510(k) clearance on 2018-10-24, under 510(k) number K180940.

Who is the listed applicant for KODEX EPD System?

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 KODEX EPD System?

The FDA product code for KODEX EPD System is DQK.

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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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