DeviceClearance

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. Device class: 2.

Clearance details

Applicant
GE Healthcare Finland Oy
Product code
Code DQA
Device class
Class 2
Regulation
21 CFR 870.2700
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Helsinki, FI
Download summary PDFView on FDA.gov ↗

Recent devices under product code DQA

view all

More clearances from GE Healthcare Finland Oy

view all

Adverse events under product code DQA

product code DQA
Death
66
Malfunction
2,867
Other
1
Total
2,934

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K093881

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K093881.

Data sourced from openFDA. This site is unofficial and independent of the FDA.