FDA 510(k)

KODEX – EPD™ System 1.5.0

Numéro K : K212493 · 2022-10-24

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

Date de décision2022-10-24

Code produitDQK

Comité consultatifCV

DécisionSubstantially Equivalent

Résumé du dispositif

KODEX – EPD™ System 1.5.0 is the device name listed in this FDA 510(k) record. The listed applicant is Philips Medical Systems Nederland, B.V. (Pmsn). It received FDA 510(k) clearance on 2022-10-24 under 510(k) number K212493. The device is classified under product code DQK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

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. The listed applicant is Philips Medical Systems Nederland, B.V. (Pmsn). The 510(k) number is K212493.

When did KODEX – EPD™ System 1.5.0 receive FDA 510(k) clearance?

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

Who is the listed applicant for KODEX – EPD™ System 1.5.0?

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

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.

Essais cliniques associés

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Dispositifs connexes (Code : DQK)

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Source officielle

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