FDA 510(k)

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

N.º K: K241411 · 2024-12-20

Fecha de decisión2024-12-20

Código de productoMWI

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del 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.

Preguntas frecuentes

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.

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Otros registros que enlistan a Welch Allyn, Inc. como solicitante

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 los 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

Fuente oficial

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