KODEX EPD System
K-Number: K180940 · 2018-10-24
Decision Date2018-10-24
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
KODEX EPD System is a medical device manufactured by Philips Medical Systems Nederland B.V.. It received FDA 510(k) clearance on 2018-10-24 under approval 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. It is manufactured by Philips Medical Systems Nederland B.V.. The 510(k) number is K180940.
When was KODEX EPD System approved by the FDA?
KODEX EPD System received FDA 510(k) clearance on 2018-10-24, under approval number K180940.
What company makes KODEX EPD System?
KODEX EPD System is manufactured by Philips Medical Systems Nederland B.V..
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.