FDA 510(k)

Welch Allyn Connex® Spot Monitor; 901058 Vital Signs Monitor Core (CSM)

Número K: K241411 · 2024-12-20

Data da decisão2024-12-20

Código do produtoMWI

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Welch Allyn Connex® Spot Monitor; 901058 Vital Signs Monitor Core (CSM) is the device name listed in this FDA 510(k) record. The listed applicant is Welch Allyn, Inc.. It received FDA 510(k) clearance on 2024-12-20 under 510(k) number K241411. 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 Welch Allyn Connex® Spot Monitor; 901058 Vital Signs Monitor Core (CSM)?

Welch Allyn Connex® Spot Monitor; 901058 Vital Signs Monitor Core (CSM) is a medical device that received FDA 510(k) clearance on 2024-12-20. The listed applicant is Welch Allyn, Inc.. The 510(k) number is K241411.

When did Welch Allyn Connex® Spot Monitor; 901058 Vital Signs Monitor Core (CSM) receive FDA 510(k) clearance?

Welch Allyn Connex® Spot Monitor; 901058 Vital Signs Monitor Core (CSM) received FDA 510(k) clearance on 2024-12-20, under 510(k) number K241411.

Who is the listed applicant for Welch Allyn Connex® Spot Monitor; 901058 Vital Signs Monitor Core (CSM)?

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

What is the FDA product code for Welch Allyn Connex® Spot Monitor; 901058 Vital Signs Monitor Core (CSM)?

The FDA product code for Welch Allyn Connex® Spot Monitor; 901058 Vital Signs Monitor Core (CSM) 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

Outros registros que listam Welch Allyn, Inc. como candidato(a)

K243598Welch Allyn Connex® 360 (Multiple)K223381iExaminer System with Panoptic Plus K212473Welch Allyn Connex Central Station K191013Welch Allyn Diagnostic Cardiology Suite 2.X.X with Spirometry option K181016Welch Allyn RetinaVue Network REF 901108 PACS Medical Image System K171621Welch Allyn Connex Vital Signs Monitor, Welch Allyn Connex Integrated Wall System, 901060 Vital Signs Monitor

Ver todos os 7 dispositivos →

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.