FDA 510(k)

MAMMI

Numéro K : K161631 · 2016-07-28

DemandeurGeneral Equipment For Medical Imaging

Date de décision2016-07-28

Code produitKPS

Comité consultatifRA

DécisionSubstantially Equivalent

Résumé du dispositif

MAMMI is the device name listed in this FDA 510(k) record. The listed applicant is General Equipment For Medical Imaging. It received FDA 510(k) clearance on 2016-07-28 under 510(k) number K161631. The device is classified under product code KPS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the MAMMI?

MAMMI is a medical device that received FDA 510(k) clearance on 2016-07-28. The listed applicant is General Equipment For Medical Imaging. The 510(k) number is K161631.

When did MAMMI receive FDA 510(k) clearance?

MAMMI received FDA 510(k) clearance on 2016-07-28, under 510(k) number K161631.

Who is the listed applicant for MAMMI?

The FDA 510(k) record lists General Equipment For Medical Imaging as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MAMMI?

The FDA product code for MAMMI is KPS.

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 : KPS)

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.