FDA 510(k)

Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal

N.º K: K242737 · 2025-06-06

Fecha de decisión2025-06-06

Código de productoMWI

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal is the device name listed in this FDA 510(k) record. The listed applicant is Empatica S.r.l.. It received FDA 510(k) clearance on 2025-06-06 under 510(k) number K242737. 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 Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal?

Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal is a medical device that received FDA 510(k) clearance on 2025-06-06. The listed applicant is Empatica S.r.l.. The 510(k) number is K242737.

When did Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal receive FDA 510(k) clearance?

Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal received FDA 510(k) clearance on 2025-06-06, under 510(k) number K242737.

Who is the listed applicant for Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal?

The FDA 510(k) record lists Empatica S.r.l. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal?

The FDA product code for Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal is MWI.

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Otros registros que enlistan a Empatica S.r.l. como solicitante

K260374Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus; EmbraceMini; Empatica Care; PKG Monitor by Empatica; Care Portal K252981EmbraceMini K250515EpiMonitor K232915EpiMonitor K230457Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal K221282Empatica Health Monitoring Platform

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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

Ver en la base de datos de la FDA →

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