FDA 510(k)

AlertWatch: OR

Número K: K153335 · 2016-03-15

Data da decisão2016-03-15

Código do produtoMWI

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

AlertWatch: OR is the device name listed in this FDA 510(k) record. The listed applicant is Alertwatch, LLC. It received FDA 510(k) clearance on 2016-03-15 under 510(k) number K153335. 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 AlertWatch: OR?

AlertWatch: OR is a medical device that received FDA 510(k) clearance on 2016-03-15. The listed applicant is Alertwatch, LLC. The 510(k) number is K153335.

When did AlertWatch: OR receive FDA 510(k) clearance?

AlertWatch: OR received FDA 510(k) clearance on 2016-03-15, under 510(k) number K153335.

Who is the listed applicant for AlertWatch: OR?

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

What is the FDA product code for AlertWatch: OR?

The FDA product code for AlertWatch: OR 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.