FDA 510(k)

ulrichINJECT CT motion

Número K: K171392 · 2017-11-09

Data da decisão2017-11-09

Código do produtoIZQ

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

ulrichINJECT CT motion is the device name listed in this FDA 510(k) record. The listed applicant is Ulrich GmbH & Co. KG. It received FDA 510(k) clearance on 2017-11-09 under 510(k) number K171392. The device is classified under product code IZQ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the ulrichINJECT CT motion?

ulrichINJECT CT motion is a medical device that received FDA 510(k) clearance on 2017-11-09. The listed applicant is Ulrich GmbH & Co. KG. The 510(k) number is K171392.

When did ulrichINJECT CT motion receive FDA 510(k) clearance?

ulrichINJECT CT motion received FDA 510(k) clearance on 2017-11-09, under 510(k) number K171392.

Who is the listed applicant for ulrichINJECT CT motion?

The FDA 510(k) record lists Ulrich GmbH & Co. KG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ulrichINJECT CT motion?

The FDA product code for ulrichINJECT CT motion is IZQ.

Ensaios clínicos relacionados

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

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

Outros registros que listam Ulrich GmbH & Co. KG como candidato(a)

K252281ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180)K251295ulrichINJECT CT Motion (XD 8000)K241850ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180)K233737ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180)K210541ulrichINJECT CT motion K202227Artus™ cervical plate system

Ver todos os 11 dispositivos →

Dispositivos Relacionados (Código: IZQ)

K262115VueJect® Ultrasound Enhancing Agent Delivery SystemACIST Medical Systems, Inc.K252281ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180)Ulrich GmbH & Co. KG K251295ulrichINJECT CT Motion (XD 8000)Ulrich GmbH & Co. KG K252689MEDRAD Centargo CT Injection System; MEDRAD Centargo Day Set; MEDRAD Centargo Patient Line; MEDRAD Centargo Replacement Spike; MEDRAD ISI2 Module (ISI2)Imaxeon Pty, Ltd.K241849MEDRAD Centargo CT Injection System; MEDRAD Centargo Day Set; MEDRAD Centargo Patient Line; MEDRAD Centargo Replacement Spike; MEDRAD ISI2 Module (ISI2)Imaxeon Pty, Ltd.K241850ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180)Ulrich GmbH & Co. KG

Fonte oficial

Ver na base de dados da FDA →

Dados provenientes da FDA Open API. Para informações mais recentes e oficiais, consulte sempre o registro oficial.