Carescape ONE +6 more— 510(k) K260656
Substantially EquivalentGE Healthcare Finland Oy
FDA 510(k) clearance K260656 for Carescape ONE +6 more, Substantially Equivalent on 2026-09-01. Applicant: GE Healthcare Finland Oy. Device class: 2.
Summary
GE Healthcare Finland Oy filed seven items under product code MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)): Carescape ONE, Carescape Dock F0, TruSignal ECG MM, TruSignal PRES MM, TruSignal TEMP MM, and TruSignal SpO2 MM in 1.8M and 3.0M versions. The record has no further detail.
Class II, 21 CFR 870.1025. Cardiovascular is both the classification panel and the review panel. It was a Traditional 510(k), decided Substantially Equivalent.
GE filed from Helsinki, Finland. The decision came 186 calendar days after receipt (February 27 to September 1, 2026).
Clearance details
- Device name as filed
- Carescape ONE; Carescape Dock F0; TruSignal ECG MM; TruSignal PRES MM; TruSignal TEMP MM; TruSignal SpO2 MM 1.8M; TruSignal SpO2 MM 3.0M
- Applicant
- GE Healthcare Finland Oy
- Product code
- Product code MHX
- Device class
- Class 2
- Regulation
- 21 CFR 870.1025
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Helsinki, FI
Recent devices under product code MHX
view allMore clearances from GE Healthcare Finland Oy
view all- K223531 — CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, CARESCAPE Canvas D19, F2 Frame (F2-01)
- K213181 — CARESCAPE B650, E-musb
- K213336 — Carescape B850, E-musb
- K213363 — CARESCAPE B450, E-musb
- K211171 — CARESCAPE Respiratory Modules E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX, E-sCAiOE, E-sCAiOVE and accessories
Adverse events under product code MHX
product code MHX- Death
- 580
- Injury
- 2,441
- Malfunction
- 12,655
- Other
- 3
- Total
- 15,679
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.