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.
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
- 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.