FDA 510(k)

Dispositivo de Infusión Intraóssea para Adultos

N.º K: K182770 · 2019-04-09

Fecha de decisión2019-04-09

Código de productoFMI

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

Adult Intraosseous Infusion Device is the device name listed in this FDA 510(k) record. The listed applicant is Einstein Works, LLC. It received FDA 510(k) clearance on 2019-04-09 under 510(k) number K182770. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Adult Intraosseous Infusion Device?

Adult Intraosseous Infusion Device is a medical device that received FDA 510(k) clearance on 2019-04-09. The listed applicant is Einstein Works, LLC. The 510(k) number is K182770.

When did Adult Intraosseous Infusion Device receive FDA 510(k) clearance?

Adult Intraosseous Infusion Device received FDA 510(k) clearance on 2019-04-09, under 510(k) number K182770.

Who is the listed applicant for Adult Intraosseous Infusion Device?

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

What is the FDA product code for Adult Intraosseous Infusion Device?

The FDA product code for Adult Intraosseous Infusion Device is FMI.

Ensayos clínicos relacionados

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

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

Otros registros que enlistan a Einstein Works, LLC como solicitante

K211395NIO-I K191258Intraosseous infusion device

Dispositivos relacionados (Código: FMI)

K261266MOWANA™ Auto DuoPENTAMASTER MEDIQ SDN BHD K261719Promisemed X-Safety Pen NeedlePromisemed Hangzhou Meditech Co., Ltd.K262427Pen Needle (Ordinary Type I, Safety Type IIA, Safety Type IIB, Safety Type IIIA, Safety Type IIIB, Safety Type IV, Safety Type V, Ordinary Type VIA, Ordinary Type VIB, Ordinary Type VIC, Safety Type VII, Ordinary Type IB, Safety type VIII, Safety Type IX, Safety Type X, Ordinary Type XI, Safety Type XII)Hh Global Technology, Inc.K260933Safety Sterile Hypodermic Needles (NR-S1816R, NR-S1916R, NR-S1925R, NR-S1938R, NR-S2016R, NR-S2025R, NR-S2038R, NR-S2051R, NR-S2116R, NR-S2125R, NR-S2138R, NR-S2151R, NR-S2216R, NR-S2225R, NR-S2238R, NR-S2251R, NR-S2316R, NR-S2325R, NR-S2338R, NR-S2351R, NR-S2516R, NR-S2525R, NR-S2538R, NR-S2551R, NR-S2516T, NR-S2525T, NR-S2538T, NR-S2551T)Hangzhou Qiantang Longyue Biotechnology Co., Ltd.K261829Profoject™ Dual-Safety Pen NeedlesCMT Health PTE., Ltd.K260739Profoject™ Pen Needles (Model A; Model B)CMT Health PTE., Ltd.

Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.