FDA 510(k)

QNext and DG-PT

Numéro K : K183390 · 2019-08-21

Date de décision2019-08-21

Code produitJPA

Comité consultatifHE

DécisionSubstantially Equivalent

Résumé du dispositif

QNext and DG-PT is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Grifols, S.A.. It received FDA 510(k) clearance on 2019-08-21 under 510(k) number K183390. The device is classified under product code JPA. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the QNext and DG-PT?

QNext and DG-PT is a medical device that received FDA 510(k) clearance on 2019-08-21. The listed applicant is Diagnostic Grifols, S.A.. The 510(k) number is K183390.

When did QNext and DG-PT receive FDA 510(k) clearance?

QNext and DG-PT received FDA 510(k) clearance on 2019-08-21, under 510(k) number K183390.

Who is the listed applicant for QNext and DG-PT?

The FDA 510(k) record lists Diagnostic Grifols, S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for QNext and DG-PT?

The FDA product code for QNext and DG-PT is JPA.

Essais cliniques associés

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Source officielle

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