FDA 510(k)

Carescape ONE; Carescape Dock F0; TruSignal ECG MM; TruSignal PRES MM; TruSignal TEMP MM; TruSignal SpO2 MM 1.8M; TruSignal SpO2 MM 3.0M

Numéro K : K260656 · 2026-09-01

Date de décision2026-09-01

Code produitMHX

Comité consultatifCV

DécisionSubstantially Equivalent

Résumé du dispositif

Carescape ONE; Carescape Dock F0; TruSignal ECG MM; TruSignal PRES MM; TruSignal TEMP MM; TruSignal SpO2 MM 1.8M; TruSignal SpO2 MM 3.0M 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 2026-09-01 under 510(k) number K260656. The device is classified under product code MHX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Carescape ONE; Carescape Dock F0; TruSignal ECG MM; TruSignal PRES MM; TruSignal TEMP MM; TruSignal SpO2 MM 1.8M; TruSignal SpO2 MM 3.0M?

Carescape ONE; Carescape Dock F0; TruSignal ECG MM; TruSignal PRES MM; TruSignal TEMP MM; TruSignal SpO2 MM 1.8M; TruSignal SpO2 MM 3.0M is a medical device that received FDA 510(k) clearance on 2026-09-01. The listed applicant is GE Healthcare Finland Oy. The 510(k) number is K260656.

When did Carescape ONE; Carescape Dock F0; TruSignal ECG MM; TruSignal PRES MM; TruSignal TEMP MM; TruSignal SpO2 MM 1.8M; TruSignal SpO2 MM 3.0M receive FDA 510(k) clearance?

Carescape ONE; Carescape Dock F0; TruSignal ECG MM; TruSignal PRES MM; TruSignal TEMP MM; TruSignal SpO2 MM 1.8M; TruSignal SpO2 MM 3.0M received FDA 510(k) clearance on 2026-09-01, under 510(k) number K260656.

Who is the listed applicant for Carescape ONE; Carescape Dock F0; TruSignal ECG MM; TruSignal PRES MM; TruSignal TEMP MM; TruSignal SpO2 MM 1.8M; TruSignal SpO2 MM 3.0M?

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 ONE; Carescape Dock F0; TruSignal ECG MM; TruSignal PRES MM; TruSignal TEMP MM; TruSignal SpO2 MM 1.8M; TruSignal SpO2 MM 3.0M?

The FDA product code for Carescape ONE; Carescape Dock F0; TruSignal ECG MM; TruSignal PRES MM; TruSignal TEMP MM; TruSignal SpO2 MM 1.8M; TruSignal SpO2 MM 3.0M is MHX.

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Autres dossiers indiquant GE Healthcare Finland Oy en tant que demandeur

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Dispositifs connexes (Code : MHX)

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 K252840M12 Telemetry SystemGlobal Instrumentation, LLC

Source officielle

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