FDA 510(k)

CARESCAPE B650, E-musb

N.º K: K213181 · 2022-04-13

Fecha de decisión2022-04-13

Código de productoMHX

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

CARESCAPE B650, E-musb is the device name listed in this FDA 510(k) record. The listed applicant is GE Healthcare Finland Oy. It received FDA 510(k) clearance on 2022-04-13 under 510(k) number K213181. The device is classified under product code MHX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the CARESCAPE B650, E-musb?

CARESCAPE B650, E-musb is a medical device that received FDA 510(k) clearance on 2022-04-13. The listed applicant is GE Healthcare Finland Oy. The 510(k) number is K213181.

When did CARESCAPE B650, E-musb receive FDA 510(k) clearance?

CARESCAPE B650, E-musb received FDA 510(k) clearance on 2022-04-13, under 510(k) number K213181.

Who is the listed applicant for CARESCAPE B650, E-musb?

The FDA 510(k) record lists GE Healthcare Finland Oy as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CARESCAPE B650, E-musb?

The FDA product code for CARESCAPE B650, E-musb is MHX.

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Otros registros que enlistan a GE Healthcare Finland Oy como solicitante

K260656Carescape ONE; Carescape Dock F0; TruSignal ECG MM; TruSignal PRES MM; TruSignal TEMP MM; TruSignal SpO2 MM 1.8M; TruSignal SpO2 MM 3.0M K260343Carescape Canvas 1000; Carescape Canvas Smart Display K223531CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, CARESCAPE Canvas D19, F2 Frame (F2-01)K213336Carescape B850, E-musb K213363CARESCAPE B450, E-musb K211171CARESCAPE Respiratory Modules E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX, E-sCAiOE, E-sCAiOVE and accessories

Ver todos los 13 dispositivos →

Dispositivos relacionados (Código: MHX)

K260656Carescape ONE; Carescape Dock F0; TruSignal ECG MM; TruSignal PRES MM; TruSignal TEMP MM; TruSignal SpO2 MM 1.8M; TruSignal SpO2 MM 3.0MGE Healthcare Finland Oy K260343Carescape Canvas 1000; Carescape Canvas Smart DisplayGE Healthcare Finland Oy K260579Infinity® Acute Care System (IACS) – VG8.1Draeger Medical Systems, Inc.K251508Telemetry Monitor (iT30, iT50)Edan Instruments, Inc.K253277Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125PGe Medical Systems Information Technologies, Inc.K254209Radius VSM and AccessoriesMasimo Corporation

Fuente oficial

Ver en la base de datos de la FDA →

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