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
- 510(k) number
- K260656
- Applicant
- GE Healthcare Finland Oy
- Decision date
- Sep 1, 2026
- Date received
- Feb 27, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- MHX
- Device type
- Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
- Device class
- Class II
- Regulation
- 21 CFR 870.1025
- Advisory committee
- Cardiovascular
- Statement or summary
- Summary
- Third party
- N
- Location
- Helsinki, FI