FDA 510(k)

Halo II Ambulatory Infusion System (also with trade names Nimbus II Ambulatory Infusion System, EVAA Ambulatory Infusion System)

Numéro K : K153193 · 2016-08-30

Date de décision2016-08-30

Code produitFRN

Comité consultatifHO

DécisionSubstantially Equivalent

Résumé du dispositif

Halo II Ambulatory Infusion System (also with trade names Nimbus II Ambulatory Infusion System, EVAA Ambulatory Infusion System) is the device name listed in this FDA 510(k) record. The listed applicant is Zyno Medical, LLC. It received FDA 510(k) clearance on 2016-08-30 under 510(k) number K153193. The device is classified under product code FRN. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Halo II Ambulatory Infusion System (also with trade names Nimbus II Ambulatory Infusion System, EVAA Ambulatory Infusion System)?

Halo II Ambulatory Infusion System (also with trade names Nimbus II Ambulatory Infusion System, EVAA Ambulatory Infusion System) is a medical device that received FDA 510(k) clearance on 2016-08-30. The listed applicant is Zyno Medical, LLC. The 510(k) number is K153193.

When did Halo II Ambulatory Infusion System (also with trade names Nimbus II Ambulatory Infusion System, EVAA Ambulatory Infusion System) receive FDA 510(k) clearance?

Halo II Ambulatory Infusion System (also with trade names Nimbus II Ambulatory Infusion System, EVAA Ambulatory Infusion System) received FDA 510(k) clearance on 2016-08-30, under 510(k) number K153193.

Who is the listed applicant for Halo II Ambulatory Infusion System (also with trade names Nimbus II Ambulatory Infusion System, EVAA Ambulatory Infusion System)?

The FDA 510(k) record lists Zyno Medical, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Halo II Ambulatory Infusion System (also with trade names Nimbus II Ambulatory Infusion System, EVAA Ambulatory Infusion System)?

The FDA product code for Halo II Ambulatory Infusion System (also with trade names Nimbus II Ambulatory Infusion System, EVAA Ambulatory Infusion System) is FRN.

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 : FRN)

K253703RemunityPRO+ Pump for Remodulin® (treprostinil) InjectionDeka R&D Corp K252015FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate TubingKoru Medical Systems, Inc.K251636Spectrum IQ Infusion System with Dose IQ Safety Software (3570009)Baxter Healthcare Corporation K251640SIGMA Spectrum Infusion Pump with Master Drug LibraryBaxter Healthcare Corporation K242752MRidium 3870 MRI Infusion Pump System (3870)Iradimed Corporation K243855BD Alaris Infusion System with Guardrails Suite MXCarefusion 303, Inc.

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.