Carescape ONE; Carescape Dock F0; TruSignal ECG MM; TruSignal PRES MM; TruSignal TEMP MM; TruSignal SpO2 MM 1.8M; TruSig
Summary
GE Healthcare Finland Oy received 510(k) clearance for Carescape ONE; Carescape Dock F0; TruSignal ECG MM; TruSignal PRES MM; TruSignal TEMP MM; TruSignal SpO2 MM 1.8M; TruSignal SpO2 MM 3.0M, a MHX device. Cleared on 2026-09-01.
Details
Source
510(k) Clearance
External ID
K260656
Action Date
2026-09-01
Status
Traditional
Category
device
Product Code
MHX
Product Description
Carescape ONE; Carescape Dock F0; TruSignal ECG MM; TruSignal PRES MM; TruSignal TEMP MM; TruSignal SpO2 MM 1.8M; TruSignal SpO2 MM 3.0M. Product code: MHX.
Company
Context & Analysis
A 510(k) clearance means the FDA determined this device is substantially equivalent to a legally marketed device. This is one of 445 device clearances issued this month. GE Healthcare Finland Oy has received 7 total clearances in our database.
GE Healthcare Finland Oy has 26 FDA actions in our database, including 19 recalls and 7 clearances.
Frequently Asked Questions
What does 510(k) clearance mean?
A 510(k) is an FDA premarket submission demonstrating that a device is substantially equivalent to a legally marketed device. It does NOT mean FDA approval — it means the device is cleared for marketing because it's similar enough to an existing cleared device. Most medical devices reach market via 510(k) rather than full PMA approval.
How often does GE Healthcare Finland Oy have FDA actions?
GE Healthcare Finland Oy has 26 FDA actions in our database, including 19 recalls and 7 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K260656" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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