FDA 510(k)

KODEX EPD System 1.5.0

K-Number: K212493 · 2022-10-24

ApplicantPhilips Medical Systems Nederland, B.V. (Pmsn)

Decision Date2022-10-24

Product CodeDQK

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

KODEX EPD System 1.5.0 is a medical device manufactured by Philips Medical Systems Nederland, B.V. (Pmsn). It received FDA 510(k) clearance on 2022-10-24 under approval number K212493. 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 1.5.0?

KODEX EPD System 1.5.0 is a medical device that received FDA 510(k) clearance on 2022-10-24. It is manufactured by Philips Medical Systems Nederland, B.V. (Pmsn). The 510(k) number is K212493.

When was KODEX EPD System 1.5.0 approved by the FDA?

KODEX EPD System 1.5.0 received FDA 510(k) clearance on 2022-10-24, under approval number K212493.

What company makes KODEX EPD System 1.5.0?

KODEX EPD System 1.5.0 is manufactured by Philips Medical Systems Nederland, B.V. (Pmsn).

What is the FDA product code for KODEX EPD System 1.5.0?

The FDA product code for KODEX EPD System 1.5.0 is DQK.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.