FDA 510(k)

Alpha Pure

Numéro K : K163117 · 2017-05-09

Date de décision2017-05-09

Code produitNJM

Comité consultatifDE

DécisionSubstantially Equivalent

Résumé du dispositif

Alpha Pure is the device name listed in this FDA 510(k) record. The listed applicant is Koroad America. It received FDA 510(k) clearance on 2017-05-09 under 510(k) number K163117. The device is classified under product code NJM. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Alpha Pure?

Alpha Pure is a medical device that received FDA 510(k) clearance on 2017-05-09. The listed applicant is Koroad America. The 510(k) number is K163117.

When did Alpha Pure receive FDA 510(k) clearance?

Alpha Pure received FDA 510(k) clearance on 2017-05-09, under 510(k) number K163117.

Who is the listed applicant for Alpha Pure?

The FDA 510(k) record lists Koroad America as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Alpha Pure?

The FDA product code for Alpha Pure is NJM.

Essais cliniques associés

Les enregistrements connexes sont mis en correspondance automatiquement à l'aide des noms, codes produits ou autres métadonnées. Une mise en correspondance n'établit pas de relation clinique, scientifique, corporative ou réglementaire vérifiée ; veuillez consulter les sources officielles liées.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Dispositifs connexes (Code : NJM)

K232827LightForce Orthodontic SystemLightforce Orthodontics K232011CleoAmerican Orthodontics K231635A-Line AdvancedBiocetec Co., Ltd.K230225DynaFlex Clear Brackets & ButtonsDyna Flex K222847Ceramic Brackets OrthometricOrthometric - Industria E Comercio DE Produtos Medicos K222764LightForce Orthodontic SystemLightforce Orthodontics

Source officielle

Voir dans la base de données FDA →

Données issues de l'API ouverte de la FDA. Pour les informations les plus récentes et faisant autorité, veuillez toujours vous référer au registre officiel.