FDA 510(k)

MedWand

Número K: K212975 · 2022-07-22

Data da decisão2022-07-22

Código do produtoMWI

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

MedWand is the device name listed in this FDA 510(k) record. The listed applicant is Medwand Solutions, Inc.. It received FDA 510(k) clearance on 2022-07-22 under 510(k) number K212975. The device is classified under product code MWI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the MedWand?

MedWand is a medical device that received FDA 510(k) clearance on 2022-07-22. The listed applicant is Medwand Solutions, Inc.. The 510(k) number is K212975.

When did MedWand receive FDA 510(k) clearance?

MedWand received FDA 510(k) clearance on 2022-07-22, under 510(k) number K212975.

Who is the listed applicant for MedWand?

The FDA 510(k) record lists Medwand Solutions, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MedWand?

The FDA product code for MedWand is MWI.

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

Dispositivos Relacionados (Código: MWI)

K260438Vital Signs Monitor (CLEO2)Infinium Medical, Inc.K253417Masimo Root Monitoring SystemMasimo Corporation K253196Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400)Midmark Corporation K253436c-med0 alphaCosinuss GmbH K250135WAVE Clinical Platform (2.0.000)Baxter Healthcare Corp/ Excel Medical K241766QMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid)Fysicon BV

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.