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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
510(k) Number K260656
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
Kuortaneenkatu 2
Helsinki,  FI FI-05100
Applicant Contact Anssi Ruokonen
Correspondent
GE Healthcare Finland Oy
Kuortaneenkatu 2
Helsinki,  FI FI-05100
Correspondent Contact Anssi Ruokonen
Regulation Number870.1025
Classification Product Code
MHX  
Subsequent Product Codes
BZQ   CCK   DPS   DPZ   DQA  
DQK   DRT   DSI   DSJ   DSK   DXN  
FLL   MLD   MUD   QEM  
Date Received02/27/2026
Decision Date 09/01/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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