TRUSIGNAL SPO2 FINGER SENSOR, TRUSIGNAL SPO2 EAR SENSOR, TRUSIGNAL SPO2 WRAP SENSOR— 510(k) K093881

Substantially Equivalent

GE Healthcare Finland Oy

FDA 510(k) clearance K093881 for TRUSIGNAL SPO2 FINGER SENSOR, TRUSIGNAL SPO2 EAR SENSOR, TRUSIGNAL SPO2 WRAP SENSOR, Substantially Equivalent on 2010-03-12. Applicant: GE Healthcare Finland Oy.

Clearance details

Applicant: GE Healthcare Finland Oy
Product code: Code DQA
Advisory panel: Cardiovascular
Date received: 2009-12-18
Decision date: 2010-03-12
Decision: Substantially Equivalent
Clearance type: Special
Location: Helsinki, FI

Download summary PDF View on FDA.gov ↗

Adverse events under product code DQA

product code DQA

Death: 66
Malfunction: 2,867
Other: 1
Total: 2,934

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.