Carescape ONE; Carescape Dock F0; TruSignal ECG MM; TruSignal PRES MM; TruSignal TEMP MM; TruSignal SpO2 MM 1.8M; TruSignal SpO2 MM 3.0M
FDA 510(k) K260656 · GE Healthcare Finland Oy
510(k) numberK260656
Submission
- Device name
- 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
Helsinki, FI - Received
- February 27, 2026
- Decision date
- September 1, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MHX – Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1025
- Specialty
- Cardiovascular
Other 510(k)s with product code MHX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260343 | Carescape Canvas 1000; Carescape Canvas Smart DisplayMHX · Traditional | GE Healthcare Finland Oy | 08/28/2026SE |
| K260579 | Infinity® Acute Care System (IACS) VG8.1MHX · Traditional | Draeger Medical Systems, Inc. | 08/20/2026SE |
| K251508 | Telemetry Monitor (iT30, iT50)MHX · Traditional | Edan Instruments, Inc. | 08/06/2026SE |
| K253277 | Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125PMHX · Traditional | Ge Medical Systems Information Technologies, Inc. | 07/24/2026SE |
| K254209 | Radius VSM and AccessoriesMHX · Traditional | Masimo Corporation | 06/04/2026SE |
| K252840 | M12 Telemetry SystemMHX · Traditional | Global Instrumentation, LLC | 05/29/2026SE |
| K260098 | ePM Series Patient Monitor (ePM 10/ePM 10A/ePM 10C/Guardian plus/ ePM 12/ePM 12A/ePM 12C…MHX · Traditional | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 05/20/2026SE |
| K250349 | Vista CMSMHX · Traditional | Shanghai Draeger Medical Instrument Co., Ltd. | 04/24/2026SE |
| K253170 | uMEC 60/ uMEC 70/ uMEC 80/uMEC 100/uMEC 120/uMEC 150 Patient MonitorsMHX · Traditional | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 04/16/2026SE |
| K252250 | Vista 300/Vista 300 S; Vista 300 Non-Inv Model A, US (2601064); Vista 300 Invasive Model…MHX · Traditional | Shanghai Draeger Medical Instrument Co., Ltd. | 04/10/2026SE |
More from Shanghai Draeger Medical Instrument Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K260343 | Carescape Canvas 1000; Carescape Canvas Smart DisplayMHX · Traditional | 08/28/2026SE |
| K223531 | CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, CARESCAPE Canvas D19, F2 Frame…MHX · Traditional | 04/06/2023SE |
| K213363 | CARESCAPE B450, E-musbMHX · Traditional | 04/13/2022SE |
| K213336 | Carescape B850, E-musbMHX · Traditional | 04/13/2022SE |
| K213181 | CARESCAPE B650, E-musbMHX · Traditional | 04/13/2022SE |
| K211171 | CARESCAPE Respiratory Modules E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX…CCK · Traditional | 10/21/2021SE |
| K191323 | Carescape B850MHX · Traditional | 01/29/2020SE |
| K191249 | Carescape B450MHX · Traditional | 01/24/2020SE |
| K191322 | E-Eegx, N-EegxOLT · Traditional | 01/22/2020SE |
| K191149 | Carescape B650MHX · Traditional | 01/21/2020SE |
Questions and answers
When was Carescape ONE; Carescape Dock F0; TruSignal ECG MM; TruSignal PRES MM; TruSignal TEMP MM; TruSignal SpO2 MM 1.8M; TruSignal SpO2 MM 3.0M cleared by the FDA?
Carescape ONE; Carescape Dock F0; TruSignal ECG MM; TruSignal PRES MM; TruSignal TEMP MM; TruSignal SpO2 MM 1.8M; TruSignal SpO2 MM 3.0M (K260656) received a 510(k) decision of Substantially Equivalent on September 1, 2026, 186 days after the submission was received.
What is the product code of K260656?
The FDA product code is MHX – Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms), a Class II (moderate risk) device regulated under 21 CFR 870.1025.