FDA 510(k)

Belmont Rapid Infuser, RI-2 (Rapid Infuser RI-2, 1000 ml/min); Belmont Rapid Infuser, RI-2 (Rapid Infuser RI-2, 750 ml/min)

Numéro K : K242735 · 2024-12-23

Date de décision2024-12-23

Code produitFRN

Comité consultatifHO

DécisionSubstantially Equivalent

Résumé du dispositif

Belmont Rapid Infuser, RI-2 (Rapid Infuser RI-2, 1000 ml/min); Belmont Rapid Infuser, RI-2 (Rapid Infuser RI-2, 750 ml/min) is the device name listed in this FDA 510(k) record. The listed applicant is Belmont Medical Technologies. It received FDA 510(k) clearance on 2024-12-23 under 510(k) number K242735. 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 Belmont Rapid Infuser, RI-2 (Rapid Infuser RI-2, 1000 ml/min); Belmont Rapid Infuser, RI-2 (Rapid Infuser RI-2, 750 ml/min)?

Belmont Rapid Infuser, RI-2 (Rapid Infuser RI-2, 1000 ml/min); Belmont Rapid Infuser, RI-2 (Rapid Infuser RI-2, 750 ml/min) is a medical device that received FDA 510(k) clearance on 2024-12-23. The listed applicant is Belmont Medical Technologies. The 510(k) number is K242735.

When did Belmont Rapid Infuser, RI-2 (Rapid Infuser RI-2, 1000 ml/min); Belmont Rapid Infuser, RI-2 (Rapid Infuser RI-2, 750 ml/min) receive FDA 510(k) clearance?

Belmont Rapid Infuser, RI-2 (Rapid Infuser RI-2, 1000 ml/min); Belmont Rapid Infuser, RI-2 (Rapid Infuser RI-2, 750 ml/min) received FDA 510(k) clearance on 2024-12-23, under 510(k) number K242735.

Who is the listed applicant for Belmont Rapid Infuser, RI-2 (Rapid Infuser RI-2, 1000 ml/min); Belmont Rapid Infuser, RI-2 (Rapid Infuser RI-2, 750 ml/min)?

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

What is the FDA product code for Belmont Rapid Infuser, RI-2 (Rapid Infuser RI-2, 1000 ml/min); Belmont Rapid Infuser, RI-2 (Rapid Infuser RI-2, 750 ml/min)?

The FDA product code for Belmont Rapid Infuser, RI-2 (Rapid Infuser RI-2, 1000 ml/min); Belmont Rapid Infuser, RI-2 (Rapid Infuser RI-2, 750 ml/min) 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.K251640SIGMA Spectrum Infusion Pump with Master Drug LibraryBaxter Healthcare Corporation K251636Spectrum IQ Infusion System with Dose IQ Safety Software (3570009)Baxter 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.