FDA 510(k)

pjur AQUA Baseline, pjur AQUA Guarana, pjur AQUA ProVitamin B5, pjur BACK DOOR anal Provitamin B5

Numéro K : K200731 · 2021-01-21

Date de décision2021-01-21

Code produitNUC

Comité consultatifOB

DécisionSubstantially Equivalent

Résumé du dispositif

pjur AQUA Baseline, pjur AQUA Guarana, pjur AQUA ProVitamin B5, pjur BACK DOOR anal Provitamin B5 is the device name listed in this FDA 510(k) record. The listed applicant is Pjur Group Luxembourg S.A.. It received FDA 510(k) clearance on 2021-01-21 under 510(k) number K200731. The device is classified under product code NUC. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the pjur AQUA Baseline, pjur AQUA Guarana, pjur AQUA ProVitamin B5, pjur BACK DOOR anal Provitamin B5?

pjur AQUA Baseline, pjur AQUA Guarana, pjur AQUA ProVitamin B5, pjur BACK DOOR anal Provitamin B5 is a medical device that received FDA 510(k) clearance on 2021-01-21. The listed applicant is Pjur Group Luxembourg S.A.. The 510(k) number is K200731.

When did pjur AQUA Baseline, pjur AQUA Guarana, pjur AQUA ProVitamin B5, pjur BACK DOOR anal Provitamin B5 receive FDA 510(k) clearance?

pjur AQUA Baseline, pjur AQUA Guarana, pjur AQUA ProVitamin B5, pjur BACK DOOR anal Provitamin B5 received FDA 510(k) clearance on 2021-01-21, under 510(k) number K200731.

Who is the listed applicant for pjur AQUA Baseline, pjur AQUA Guarana, pjur AQUA ProVitamin B5, pjur BACK DOOR anal Provitamin B5?

The FDA 510(k) record lists Pjur Group Luxembourg S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for pjur AQUA Baseline, pjur AQUA Guarana, pjur AQUA ProVitamin B5, pjur BACK DOOR anal Provitamin B5?

The FDA product code for pjur AQUA Baseline, pjur AQUA Guarana, pjur AQUA ProVitamin B5, pjur BACK DOOR anal Provitamin B5 is NUC.

Essais cliniques associés

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Source officielle

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