FDA 510(k)

Carescape Canvas 1000; Carescape Canvas Smart Display

N.º K: K260343 · 2026-08-28

Fecha de decisión2026-08-28

Código de productoMHX

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

Carescape Canvas 1000; Carescape Canvas Smart Display 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 2026-08-28 under 510(k) number K260343. 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 Canvas 1000; Carescape Canvas Smart Display?

Carescape Canvas 1000; Carescape Canvas Smart Display is a medical device that received FDA 510(k) clearance on 2026-08-28. The listed applicant is GE Healthcare Finland Oy. The 510(k) number is K260343.

When did Carescape Canvas 1000; Carescape Canvas Smart Display receive FDA 510(k) clearance?

Carescape Canvas 1000; Carescape Canvas Smart Display received FDA 510(k) clearance on 2026-08-28, under 510(k) number K260343.

Who is the listed applicant for Carescape Canvas 1000; Carescape Canvas Smart Display?

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 Canvas 1000; Carescape Canvas Smart Display?

The FDA product code for Carescape Canvas 1000; Carescape Canvas Smart Display 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 K223531CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, CARESCAPE Canvas D19, F2 Frame (F2-01)K213336Carescape B850, E-musb K213181CARESCAPE B650, 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 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 K252840M12 Telemetry SystemGlobal Instrumentation, LLC

Fuente oficial

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